This Decision promulgates technical standards for veterinary pharmaceuticals such as sodium bicarbonate, nitroxynil 25%, chloramine B, chloramine T, flumequin, oral flumequin 20%, amprolium hydrochloride 10% and 20%, iron (II) oxalate, and amprolium hydrochloride. These standards specify requirements regarding properties, quantification, testing methods, and storage of each pharmaceutical.
Scope of application
Veterinary pharmaceutical manufacturing enterprises, state management agencies for product quality, and related organizations in the veterinary pharmaceutical sector.
Key points
- Veterinary pharmaceutical manufacturing enterprises must comply with the technical standard of sodium bicarbonate (84.01%).
- The nitroxynil 25% content must be ±10%.
- Chloramine B and chloramine T must have an active chlorine content from 98-103%.
- Flumequin must contain flumequin from 93-102%.
- Amprolium hydrochloride 10% and 20% must have an amprolium hydrochloride content of ±10%.
- Iron (II) oxalate must contain at least 98% C2O4Fe.2H2O.
- Testing methods such as property inspection, quantification by spectroscopy and liquid chromatography must be carried out.
🌐 Social impact of this document
- To ensure the quality of veterinary drugs on the market and increase the effectiveness of animal disease treatment.
- Reduce the risk of using substandard drugs that may harm animal and human health.
- Establish clear standards for manufacturers to comply with.
❓ Frequently asked questions
What percentage ratio must sodium bicarbonate achieve?
Sodium bicarbonate must contain at least 84.01%.
What tolerance is allowed for the nitroxynil 25% content?
The nitroxynil 25% content is allowed a tolerance of ±10%.
What must be the active chlorine content for chloramine B and chloramine T?
Chloramine B and chloramine T must have an active chlorine content from 98-103%.
What must be the flumequin content for flumequin?
Flumequin must contain flumequin from 93-102%.
What must be the amprolium hydrochloride content for amprolium hydrochloride 10% and 20%?
Amprolium hydrochloride 10% and 20% must have an amprolium hydrochloride content of ±10%.
Full text
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MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT |
SOCIALIST REPUBLIC OF VIET NAM |
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Number: 50/2002/QĐ-BNN |
Hanoi, June 12, 2002 |
DECISION
Regarding the issuance of veterinary drug standards
THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT
- Pursuant to Decree No. 73/CP dated November 1, 1995 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;
- Pursuant to Decree No. 86/CP dated December 8, 1995 of the Government "Regulating the division of responsibilities for state management of product quality";
- Pursuant to Decision No. 135/QĐ-BNN-KHCN of the Minister of Agriculture and Rural Development issued on October 1, 1999 regarding the regulation on the establishment, review, and issuance of industry standards;
- Considering the proposal of the Director of the Department of Science, Technology, and Standardization.
Pursuant to …;:
Article 1:Now hereby promulgates the following standards:
- 10 TCN 535-2002: Technical standard of sodium bicarbonate (natri bicacbonat);
- 10 TCN 536-2002: Technical standard of nitroxynil injection 25%;
- 10 TCN 537-2002: Technical standard of chloramine B;
- 10 TCN 538-2002: Technical standard of chloramine T;
- 10 TCN 539-2002: Technical standard of Flumequin;
- 10 TCN 540-2002: Technical standard of Flumequin oral solution 20%;
- 10 TCN 541-2002: Technical standard of amprolium chloride powder 10%, 20%;
- 10 TCN 542-2002: Technical standard of iron (II) oxalate tablets 0.05g;
- 10 TCN 543-2002: Technical standard of iron (II) oxalate;
- 10 TCN 544-2002: Technical standard of amprolium chloride.
Article 2:THIS DECISION SHALL TAKE EFFECT 15 DAYS FROM THE DATE OF SIGNATURE.
Article 3:The Heads of the Ministry's Office, the Director of the Department of Science, Technology, and Standardization, and the Heads of related units are responsible for implementing this Decision./.
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DECISION OF THE MINISTER OF AGRICULTURE |
INDUSTRY STANDARD
10 TCN 535 - 2002
TECHNICAL STANDARD OF SODIUM BICARBONATE (NATRI BICACBONAT)
HANOI-2002
Group B
TECHNICAL STANDARD OF SODIUM BICARBONATE (NATRI BICACBONAT)
Technical standard of sodium bicarbonate
NaHCO3 = 84,01
b) In cases where funds from organizations and individuals within and outside Vietnam are used for victim support work and victim support benefits, such activities shall be carried out in accordance with the regulations of the Ministry of Finance and the donor; in cases where there is no agreement between the donor or their authorized representative and the Ministry of Finance regarding the expenditure level, the expenditure level prescribed in this Circular shall apply.:This standard applies to sodium bicarbonate, raw material for preparing various types of drugs used in veterinary medicine.
2. Technical requirements:2.1. Properties: White crystalline powder, odorless, salty taste, soluble in water, insoluble in 95% alcohol. Solution has slightly alkaline reaction.
2.2. Qualitative test: Raw material must have the reaction of sodium bicarbonate.
2.3. Quantitative test: Raw material must contain at least 98.5% NaHCO3.
3. Testing Methods:3.1. Properties: Inspected visually, raw material must meet the requirements stated above.
3.2. Qualitative test:
3.2.1. Reagents (TT):
- Acetic acid solution (TT);
- Phenolphthalein solution (CT);
- Magnesium uranyl acetate solution (TT);
- Hydrochloric acid solution (TT).
3.2.2. Testing method:
- Take several grains of raw material and place them in a colorless flame; the flame will turn yellow.
- Take 0.5 ml of 5% raw material solution neutralized with acetic acid (TT) using phenolphthalein indicator, then add magnesium uranyl acetate solution (TT), which will precipitate yellow crystals.
- Add dilute hydrochloric acid (TT) to the raw material, bubbles of carbon dioxide gas will be released vigorously. If the gas is passed through a test tube containing lime water, white precipitate will appear.
3.3. Quantitative test:
3.3.1. Reagents:
- 1N hydrochloric acid solution;
- Methyl orange solution (CT).
3.3.2. Testing method:
Weigh accurately about 1.5g of raw material, dissolve it in 50ml of distilled water that has just been boiled and cooled, then titrate with 1N hydrochloric acid solution (indicator methyl orange).
1ml of hydrochloric acid solution corresponds to 0.0840g NaHCO3.
4. Storage: In a sealed container.Reference materials
- Vietnamese Pharmacopoeia II
- British Pharmacopoeia BP 88
10 TCN 536 - 2002
TECHNICAL STANDARD OF NITROXYNIL INJECTION 25%
HANOI-2002
Group B
INDUSTRY STANDARD 10 TCN 536 - 2002
TECHNICAL STANDARD OF NITROXYNIL INJECTION 25%
Technical standard of nitroxynil injection 25%
This standard applies to nitroxynil injection used in veterinary medicine.
2. Technical requirements:2.1. Formulation:
Nitroxynil 250g (Two hundred fifty grams);
Excipients and distilled water to make up 1000ml.
2.2. Raw materials:
Nitroxynil meeting national production standards or BP (Vet) 1998;
Excipients meeting national production standards;
Sterile distilled water for injection meeting Vietnamese Pharmacopoeia II standards.
2.3. Quality, composition:
2.3.1. External appearance: The drug is packaged in glass bottles with tight caps or sealed glass ampoules. Labels comply with regulations.
2.3.2. Clarity and color: Red-colored solution.
2.3.3. Volume: Allowable volume variation ± 10%.
2.3.4. pH: 5 – 7.
2.3.5. Qualitative test: The preparation exhibits a characteristic UV absorption spectrum of nitroxynil.
2.3.6. Quantitative test: Nitroxynil content allowed variation ± 10% compared to label claim.
2.3.7. Sterility: Meets sterility standards for injectable drugs according to Vietnamese Pharmacopoeia II, Part 3.
3. Testing Methods:3.1. Appearance: Inspect visually, the preparation must meet the requirements stated in section 2.3.1.
3.2. Clarity and color: Inspect visually, the preparation must meet the requirements stated in section 2.3.2.
3.3. Volume: Measure average volume. Allowable volume variation within ± 10%.
3.4. pH: According to Appendix 3.15 (pH determination) Vietnamese Pharmacopoeia II, Part 3.
3.5. Qualitative test:
3.5.1. Reagents (TT):
- 0.01N sodium hydroxide solution;
- Dilute sulfuric acid solution (TT).
3.5.2. Testing method:
- Treat the sample as in quantitative testing. The solution obtained in the range from 240 to 350nm shows a characteristic UV absorption spectrum of nitroxynil with only one maximum absorption at 271nm;
- Heat 0.5ml of the preparation with 3ml of sulfuric acid, an iodine smell will emanate.
3.6. Quantitative test:
3.6.1. Reagents:
- 0.01N sodium hydroxide solution
3.6.2. Testing method:
Take an amount of preparation equivalent to approximately 1.7g of nitroxynil, add 0.01N sodium hydroxide solution to 500ml, dilute 20ml of this solution to 500ml with 0.01N sodium hydroxide solution.
Take 5ml of this solution and further dilute to 100ml with 0.01N NaOH solution. Measure the absorbance of the solution at lmax 271nm.
Reference blank is 0.01N NaOH
Calculate results:
The specific absorbance of the nitroxynil solution A(1% - 1cm) is 660 at lmax271nm.
3.7. Sterility:
Test sterility according to the method described in Vietnamese Pharmacopoeia II, Part 3
4. Storage: In a cool, dry place, away from light
References.- BP (Vet) 1998
10 TCN 537 - 2002
TECHNICAL STANDARD OF CHLORAMINE B (CLORAMIN B)
TECHNICAL STANDARD OF CHLORAMINE B
HANOI-2002
Group B
Technical standard of Chloramine B
C6H5O2NClSNa.3H2O = 267,67
This standard applies to chloramine B, raw material used for producing various types of drugs used in veterinary medicine.
b) In cases where funds from organizations and individuals within and outside Vietnam are used for victim support work and victim support benefits, such activities shall be carried out in accordance with the regulations of the Ministry of Finance and the donor; in cases where there is no agreement between the donor or their authorized representative and the Ministry of Finance regarding the expenditure level, the expenditure level prescribed in this Circular shall apply.:2.1. Properties: White crystals or slightly yellow, faint chlorine odor.
2. Technical requirements:Solubility: Easily soluble in boiling water, soluble in cold water or alcohol, insoluble in ether, chloroform, benzene.
Solubility: Easily soluble in boiling water, soluble in cold water or alcohol, insoluble in ether, chloroform, benzene.
The raw material solution reacts with phenolphthalein and changes red litmus paper to blue, then gradually loses color.
2.2. Qualitative test: The raw material must react with chloramine B.
2.3. Quantitative test: The raw material must contain 25 – 29% active chlorine.
3. Testing Methods:3.1. Characteristics: Inspect visually; the raw material must meet the requirements stated.
3.2. Qualitative test:
3.2.1. Reagents:
- Potassium iodide solution (TT)
- Chloroform (TT)
3.2.2. Testing method:
- Dissolve 0.05g of the raw material in 5ml of distilled water, add 1ml of potassium iodide solution (TT) and shake with 1ml of chloroform (TT); the chloroform layer will turn purple.
- Burn 0.20g of chloramine B raw material in a porcelain crucible; the raw material will suddenly emit light and decompose. The residue left after burning to red will dye a colorless flame yellow and give a sulfate reaction.
3.3. Quantitative test:
3.3.1. Reagents:
- 10% potassium iodide solution (TT)
- 10% hydrochloric acid solution (TT)
- Starch paste solution (CT)
- 0.1N sodium thiosulfate solution
3.3.2. Method:
Accurately weigh 1.50g of the raw material, dissolve it in 50ml of distilled water in a 100ml volumetric flask and dilute to the mark with water. Shake well and take 25ml of the resulting solution into a 250ml conical flask with a ground stopper, add 10ml of potassium iodide solution (TT), 10ml of diluted hydrochloric acid solution (TT) and titrate the liberated iodine with 0.1N sodium thiosulfate solution (starch indicator).
1ml of 0.1N sodium thiosulfate solution corresponds to 0.003546g of active chlorine.
4. Storage: Protect from light, heat, and moisture.Reference materials
- Vietnamese Pharmacopoeia I
- Socialist Republic of Vietnam
Ministry of Agriculture and Rural Development
10 TCN 538 - 2002
TECHNICAL STANDARD FOR CHLORAMINE T (CHLORAMINE T)
HANOI-2002
Group B
TECHNICAL STANDARD FOR CHLORAMINE T TECHNICAL STANDARD OF CHLORAMINE T
C7H7CLNNAO2S.3H2O = 281,75
This procedure applies to chloramine T, a raw material used for producing veterinary drugs.
2. Technical requirements:2.1. Characteristics: White crystalline powder or slightly yellow, with a chlorine odor, easily soluble in water, soluble in alcohol, insoluble in ether, chloroform, benzene.
The raw material solution (1/20) reacts with phenolphthalein and changes red litmus paper to blue, then gradually loses color.
2.2. Qualitative test: The raw material must react with chloramine T.
2.3. Quantitative test: The raw material must contain 98 – 103% C7H7ClNNaO2S.3H2O.
3. Testing Methods:3.1. Properties: Inspected visually, raw material must meet the requirements stated above.
3.2. Qualitative test:
3.2.1. Reagents (TT):
- Diluted hydrochloric acid solution (TT);
- Sodium hydroxide solution (TT);
- Potassium iodide solution (TT);
- Chloroform (TT);
- 1/10 sodium bromide solution.
3.2.2. Testing method:
Dissolve 0.20g of the raw material in 5ml of distilled water, acidify with diluted hydrochloric acid solution (TT) which will form a white precipitate that dissolves in excess sodium hydroxide solution (TT).
- Dissolve 0.05g of the raw material in 5ml of distilled water, add 1ml of potassium iodide solution (TT) and shake with 1ml of chloroform (TT); the chloroform layer will turn purple.
Dropwise add 1/30 of 1/10 sodium bromide solution (TT) to the raw material solution without releasing bromine vapor (to distinguish from dichloramine).
3.3. Quantitative test:
3.3.1. Reagents:
- 10% potassium iodide solution (TT);
- Diluted hydrochloric acid solution (TT);
- Starch paste solution (CT);
- 0.1N sodium thiosulfate solution.
3.3.2. Method:
Accurately weigh 0.30g of the raw material, dissolve it in 50ml of distilled water in a conical flask with a ground stopper. Add 10ml of 10% potassium iodide solution (TT), 10ml of diluted hydrochloric acid solution (TT). Let stand for 15 minutes, then titrate the liberated iodine with 0.1N sodium thiosulfate solution (starch indicator).
1ml of 0.1N sodium thiosulfate solution corresponds to 0.01409g of C7H7ClNNaO2S.3H2O.
4. Storage: Protect from light, heat, and moisture.Reference materials
- Vietnamese Pharmacopoeia II
British Pharmacopoeia
10 TCN 539 - 2002
TECHNICAL STANDARD FOR FLUMEQUIN (FLUMEQUINE)
HANOI-2002
Group B
TECHNICAL STANDARD FOR FLUMEQUIN TECHNICAL STANDARD OF FLUMEQUINE
C14H12NO3F = 261,25
This procedure applies to flumequin, a raw material used for producing veterinary drugs.
2. Technical requirements:2.1. Characteristics: White or nearly white powder, odorless, soluble in alkaline solutions, insoluble in water.
2.2. Qualitative test: The raw material gives a characteristic UV absorption spectrum of flumequin.
2.3. Quantitative test: Content of flumequin from 93 – 102%.
3. Testing Methods:3.1. Properties: Inspected visually, raw material must meet the requirements stated above.
3.2. Qualitative test:
3.2.1. Reagents (TT):
- 1M sodium hydroxide solution (TT).
3.2.2. Testing method:
Record the UV absorption spectrum of the treated raw material solution in the quantitative section. Compare with the standard spectrum of flumequin.
3.3. Quantitative test:
3.3.1. Reagents:
- 1M sodium hydroxide solution.
3.3.2. Method:
Accurately weigh about 0.2g of the raw material into a 100ml volumetric flask. Add about 20ml of distilled water and 5ml of 1M sodium hydroxide solution, dissolve. Dilute to the mark with distilled water. Take 5ml of this solution into a 500ml volumetric flask and dilute with distilled water to the mark. Measure absorbance at λmax 330nm.
The blank is distilled water.
Calculate the result: Take the specific absorbance A(1% - 1cm) at 330nm as 434.
4. Storage: Pack in sealed containers, store in cool place, protected from light.Reference materials
European Pharmacopoeia
10 TCN 540 - 2002
TECHNICAL STANDARD FOR ORAL SOLUTION FLUMEQUIN 20% (FLUMEQUINE 20%)
HANOI-2002
GROUP B
TECHNICAL STANDARD FOR ORAL SOLUTION FLUMEQUIN 20%
Technical standard of flumequin oral solution 20%
This procedure applies to flumequin oral solution 20%, used in veterinary medicine.
2. Technical requirements:2.1. Formulation:
Flumequin 200g (Two hundred grams);
Excipients and distilled water q.s. 1000ml.
2.2. Raw materials:
Flumequin meets production standards.
Excipients meeting national production standards;
Distilled water meets Vietnamese Pharmacopoeia II standards.
2.3. Quality, composition:
2.3.1. External appearance: The preparation is packed in glass bottles with tight caps. Labels comply with regulations.
2.3.2. Clarity and color: Clear yellowish solution.
2.3.3. Volume: Allowable volume variation ± 10%.
2.3.4. pH: 10 – 11
2.3.5. Qualitative test: The preparation must give the characteristic UV absorption spectrum of flumequin.
2.3.6. Quantitative test: The labeled content of flumequin may be ± 10%.
3. Testing Methods:3.1. Appearance: Inspect visually; the preparation must meet the requirements stated.
3.2. Clarity and color: Inspect visually; the preparation must meet the requirements stated.
3.3. Volume: Measure average volume. Allowable volume variation within ± 10%.
3.4. pH: See Appendix 315 (determining pH) of Vietnamese Pharmacopoeia II, Volume 3.
3.5. Qualitative test:
3.5.1. Reagents (TT):
- 1M sodium hydroxide solution (TT).
3.5.2. Testing method:
Record the UV absorption spectrum of the treated solution in the quantitative section. This solution's absorption spectrum must have a maximum absorption at 330nm.
3.6.1. Reagents:
3.6.1. Quantitative determination of flumequin by spectrophotometry
3.6.1.1. Reagents:
- 1M sodium hydroxide solution
3.6.1.2. Method:
Accurately measure 5ml of the preparation solution into a 500ml volumetric flask. Dilute to the mark with distilled water and mix thoroughly. Take 5ml of this solution into another 500ml volumetric flask, add about 200ml of distilled water and 5ml of 1M sodium hydroxide solution, dilute to the mark with distilled water and mix thoroughly. Measure the absorbance of this solution at 330nm.
The blank is distilled water.
Calculate the result: Take the specific absorbance A(1% - 1cm) at 330nm as 434. Calculate according to the formula:
Flumequin % w/w
Where: - A: absorbance of the sample solution at 330nm
- 434 = A1cm1% of flumequin at 330nm
3.6.2. Quantitative determination of flumequin by liquid chromatography
3.6.2.1. Reagents:
- Acetonitrile (HPLC)
- Tetrabutylammonium hydrogen sulfate 0.5% (w/v)
- Phosphoric acid
||| 3.6.2.2. Method of testing:
* Chromatographic conditions:
- Column: 1 stainless steel column 250 x 4.6mm, stationary phase is octadecylsilica;
- UV detector: 230nm;
- Flow rate: 1ml/min;
- Mobile phase: Tetrabutylammonium hydrogen sulfate 0.5% (w/v) in water - Acetonitrile – Phosphoric acid at a ratio of (175:75:1 v/v/v). Mix thoroughly, degas;
- Injection volume: 20μl.
||| * Sample preparation:
- Test solution (a): Dissolve 25mg of the sample in 100ml of mobile phase.
- Test solution (b): Dissolve 100mg of the sample in 20ml of acetonitrile and dilute to 100ml with mobile phase.
- Standard solution (a): Dissolve 25mg of flumequin standard in 100ml of mobile phase.
- Standard solution (b): Dissolve 5mg of 6-fluoro-2-methyl, 1,2,3,4-tetrahydroquinoline standard in 100ml of mobile phase.
- Standard solution (c): Dissolve 5mg of defluoroflumequine standard in 100ml of mobile phase.
- Standard solution (d): Dissolve 5mg of flumequine ethylester standard in 100ml of mobile phase.
- Standard solution (e): Dissolve 5mg of chloroflumequine standard in 100ml of mobile phase.
- Standard solution (f): Mix 1ml of standard solution (a), 5ml of standard solution (b), 5ml of standard solution (c), 5ml of standard solution (d), and 5ml of standard solution (e).
- Standard solution (g): Mix 10ml of standard solution (b), 10ml of standard solution (c), 10ml of standard solution (d), 10ml of standard solution (e) and dilute to 100ml with mobile phase.
Inject 20μl of standard solution (f). Adjust the detector sensitivity so that the peaks obtained have appropriate heights in the middle range of the curve. The test is invalid if the ratio between peak 1 (6-fluoro-2-methyl-1,2,3,4-tetrahydroquinoline) and peak 2 (defluoroflumequine) is less than 20; peak (flumequine ethylester) 2 and 3 is less than 1.5; peak (flumequine) 3 and 4 is less than 3; and peak (chloroflumequine) 4 and 5 is less than 10.
Inject standard solution (a) six times. The test is invalid if the peaks of related impurities of flumequin are not less than 1%.
Independently inject 20μl of standard solution (a) and test solution (a) into the chromatographic system, record the chromatogram. Calculate the percentage of flumequin based on the area or height of the peaks obtained from the chromatogram.
4. Storage: In a cool, dry place, away from light.Reference materials
- European Pharmacopoeia
10 TCN 541 - 2002
TECHNICAL STANDARD OF AMPROLIUM HYDROCHLORIDE POWDER 10%, 20%
(Amprolium Hydrochloride 10%, 20%)
HANOI-2002
Group B
TECHNICAL STANDARD OF AMPROLIUM HYDROCHLORIDE POWDER 10%, 20%
This procedure applies to amprolium hydrochloride powder 10%, 20% for veterinary use.
||| - Amprolium HCl 10g (or 20g) (Ten grams or twenty grams);
2. Technical requirements:2.1. Formulation:
||| - Excipients as needed to make up 100g.
- Amprolium HCl meets production standards;
2.2. Raw materials:
- Excipients meet the standards of the Vietnamese Pharmacopoeia I.
2.3.1. External appearance: The drug is packaged in sealed bags. Labels must be printed according to regulations.
2.3. Quality, composition:
2.3.2. Properties: White, loose, uniform powder.
2.3.3. Weight: The packaging weight may vary by ± 10%.
2.3.4. Identification: The preparation gives a characteristic UV absorption spectrum of amprolium hydrochloride.
2.3.5. Assay: The content of amprolium hydrochloride may vary by ± 10% compared to the label.
3.1. External appearance: Check visually, the preparation must meet the requirements stated.
3. Testing Methods:3.2. Properties: Check visually, the preparation must meet the requirements stated.
3.3. Weight: Weigh using a technical scale, the average weight may vary by ± 10%.
3.4. Identification:
3.4.1. Reagents (TT):
- 1N hydrochloric acid solution.
3.4.2. Method:
Record the UV absorption spectrum of the preparation solution as in the assay section. The spectrum obtained should match the standard spectrum of amprolium HCl.
3.5. Assay:
3.5.1. Reagents:
Accurately weigh about 0.5g of 20% powder and 1g of 10% powder, place them in a 100ml volumetric flask, dissolve with distilled water, dilute to the mark, mix well, filter if necessary. Take 10ml of this solution into a 500ml volumetric flask, add 350ml of distilled water, 5ml of 1N HCl diluted with distilled water to the mark, mix well. Record the UV absorption spectrum of this solution at λmax 246nm.
3.4.2. Method:
3.5.2. Testing method:
The blank is distilled water.
Calculate the result: Take the specific absorbance A(1% - 1cm) at 246nm as 424.6.
4. Storage: In a cool, dry place
10 TCN 542 - 2002TECHNICAL STANDARD OF IRON (II) OXALATE TABLETS 0.05G
TECHNICAL STANDARD OF IRON (II) OXALATE TABLETS 0.05G
HANOI-2002
Group B
Technical standard of iron (II) oxalate tablet 0.05gr
This procedure applies to iron (II) oxalate tablets for veterinary use.
- Iron (II) oxalate 0.05g (five centigrams);
2. Technical requirements:2.1. Formulation:
- Rice flour 0.10g (ten centigrams);
- Kaolin 0.03g (three centigrams);
- Talc powder 0.005g (five milligrams);
- Excipients as needed to make one tablet.
- Iron (II) oxalate meets production standards;
2.2. Raw materials:
- Excipients: kaolin, talc powder meet the standards of the Vietnamese Pharmacopoeia I; rice flour meets 52 TCN 230 - 87.
2.3.1. Appearance:
2.3. Quality, composition:
Light yellow tablets, odorless, slightly fishy taste, all tablets are uniformly colored, edges intact, no foreign matter.
2.3.2. Mechanical strength: Meets Vietnam standard TCVN 916 - 70 (Vietnamese Pharmacopoeia I).
2.3.3. Tablet weight variation: The weight of one tablet compared to the average tablet weight may vary by 15% for tablets ≤ 25mg; 10% for tablets > 25mg.
2.3.4. Disintegration time: Not more than 15 minutes.
2.3.5. Identification: Must show reactions for iron and oxalate.
2.3.6. Assay: The content of iron oxalate in each tablet may vary by
± 10% compared to the label.
3.2. Mechanical strength: According to TCVN 916 - 70 Vietnamese Pharmacopoeia I.
3. Testing Methods:3.1. Appearance: Inspect visually; the preparation must meet the requirements stated.
3.3. Tablet weight variation: According to TCVN 916 - 70 Vietnamese Pharmacopoeia I.
3.4. Disintegration time: According to TCVN 916 - 70 Vietnamese Pharmacopoeia II.
- Sodium hydroxide solution 1N (TT);
3.5. Qualitative test:
3.5.1. Reagents (TT):
- 10% acetic acid solution (TT);
- 10% calcium chloride solution (TT);
- 10% hydrochloric acid solution (TT);
- 5% potassium ferrocyanide solution (TT).
Oxalate: Grind two tablets into powder, add 5ml of 1N sodium hydroxide solution, boil for 1-2 minutes. Cool, acidify the filtrate with 10% acetic acid solution, then add 0.5ml of 10% calcium chloride solution, white precipitate will form.
3.5.2. Testing method:
Iron: Take a portion on filter paper, dissolve with 10% dilute hydrochloric acid solution (TT), add 2-3 drops of 5% potassium ferrocyanide solution (TT), it will turn blue or form a blue precipitate.
- Sodium carbonate (TT);
3.6.1. Reagents:
- 0.01N sodium hydroxide solution
- 20% sulfuric acid solution;
- 0.1N potassium permanganate solution.
||| 3.6.2. Method:
3.6.2. Method of test:
Weigh 20 tablets and grind them into a fine powder. Accurately weigh an amount of tablet powder corresponding to approximately 10 iron oxalate tablets, place it in a beaker containing 30 ml distilled water, add 1.5 g sodium carbonate (Circular), heat until boiling. Allow to cool, quickly transfer to a 100 ml volumetric flask, rinse the beaker thoroughly and concentrate the rinse into the volumetric flask. Add distilled water to the mark, shake well for 2 minutes. Allow to settle and filter, discard the first 10 ml of filtrate. Take exactly 20 ml of the subsequent filtrate into a conical flask, acidify with 20 ml of 20% sulfuric acid and heat to about 40 – 50°C. Titrate with 0.1N potassium permanganate solution until a persistent pink color appears.
1 ml of 0.1N potassium permanganate solution is equivalent to 0.008995 g of FeC2O4.2H2O.
4. Storage: Store in bottles, dry clean sealed packaging with clear printed labels as prescribed. Keep in a cool place.
Reference materials
- Vietnamese Pharmacopoeia I
- Technical standard for the medical industry
- British Pharmacopoeia BP 88
10 TCN 543 - 2002
TECHNICAL STANDARD FOR IRON (II) OXALATE
HANOI-2002
Group B
TECHNICAL STANDARD FOR IRON (II) OXALATE
Technical standard of iron (II) oxalate
FeC2O4.2H2O = 179.9
This procedure applies to iron (II) oxalate, raw material used to prepare various types of veterinary drugs.
2. Technical requirements:2.1. Properties: Yellowish crystalline powder, odorless, slightly metallic taste.
Solubility: Insoluble in water, insoluble in alcohol, soluble in cold dilute hydrochloric acid and hot dilute sulfuric acid.
2.2. Qualitative test: The raw material must give the reaction of iron (II) oxalate.
2.3. Quantitative test: The raw material must contain at least 98% FeC2O4.2H2O.
3. Testing Methods:3.1. Properties: Inspected visually, raw material must meet the requirements stated above.
3.2. Qualitative test:
3.2.1. Reagents (TT):
- 10% acetic acid solution (TT);
- Calcium chloride solution (Circular);
- Dilute acetic acid solution (Circular);
- 5% potassium ferrocyanide solution (Circular);
- Dilute hydrochloric acid (Circular).
3.2.2. Testing method:
When burned in a test tube, the raw material will leave black iron oxide residue, when calcined in air it will leave brown ferric oxide residue.
Boil 0.10 g of raw material with 5 ml of 1N sodium hydroxide solution, then filter, acidify the filtrate with dilute acetic acid (Circular) and add 0.5 ml of calcium chloride solution (Circular) to precipitate white. Dissolve the remaining residue on the filter paper in dilute hydrochloric acid (Circular) and add a few drops of 5% potassium ferrocyanide solution (Circular) to precipitate blue.
3.3. Quantitative test:
3.3.1. Reagents:
- 20% sulfuric acid solution;
- 20% sulfuric acid solution (Circular);
||| 3.6.2. Method:
3.3.2. Method:
Weigh accurately about 1 g of raw material, boil with a solution of 3 g sodium carbonate (Circular) dissolved in 50 ml distilled water. Transfer the obtained mixture to a 100 ml volumetric flask and add distilled water to the mark, shake to allow settling and filtration. Discard the first 15 ml of filtrate, take 20 ml of the subsequent filtrate, acidify with 20 ml of 20% sulfuric acid solution (Circular) and heat to about 40 – 50°C.
Titrate with 0.1N potassium permanganate solution until a persistent pink color appears.
1 ml of 0.1N potassium permanganate solution is equivalent to 0.008995 g of FeC2O4.2H2O.
4. Storage: In tightly closed bottles.Reference materials
- Vietnamese Pharmacopoeia I
10 TCN 544 - 2002
TECHNICAL STANDARD FOR AMPROLIUM HYDROCHLORIDE
HANOI-2002
Group B
TECHNICAL STANDARD FOR AMPROLIUM HYDROCHLORIDE
Technical standard of amprolium hydrochloride
C14H19ClN4.HCl = 315.3
This procedure applies to amprolium, raw material used to produce various types of veterinary drugs.
2. Technical requirements:2.1. Properties: White or nearly white powder, odorless or nearly odorless.
Solubility: Soluble in distilled water, slightly soluble in ethanol (96%), very slightly soluble in ether, almost insoluble in chloroform.
2.2. Qualitative test: The raw material gives a characteristic absorption spectrum of amprolium hydrochloride.
2.3. Quantitative test: Amprolium hydrochloride content from 97.5 to 101% calculated based on dried raw material.
3. Testing Methods:3.1. Properties: Check visually, the product must meet the requirements stated.
3.2. Qualitative test:
3.2.1. Reagents (TT):
- 0.1N dilute hydrochloric acid solution;
- Napthol solution;
- 10% nitric acid solution (Circular);
- 2% silver nitrate solution (Circular).
3.2.2. Testing method:
Absorption in the range of 230 – 350 nm, the 0.002% w/v solution of raw material in 0.1N hydrochloric acid has two maxima at 246 nm and 262 nm. The absorbance at these maxima is approximately 0.84 and approximately 0.80 respectively.
- Take 1 mg of raw material and add 5 ml of napthol solution, a dark purple color appears.
- Take 5 mg of raw material and dissolve in 2 ml distilled water, add 1 ml of 10% HNO3, add a few drops of 2% silver nitrate solution, a white precipitate forms.
3.3. Quantitative test:
3.3.1. Reagents:
- 0.1N hydrochloric acid solution.
3.3.2. Method:
Dilute the raw material to obtain a solution containing 20 mg of amprolium in 1 ml. Measure the absorbance of this solution at lmax 246 nm.
Calculate the result: Take the specific absorbance A(1% - 1 cm) at l 246 nm as 424.6.
4. Storage: In sealed packaging, cool place, avoid light.Relations map
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