State drugs controller cum controlling and approving authority - Haryana
National Accreditation Board for Testing and calibration Laboratories (NABL)
FSSAI Approval Vide Reg. No 30/N/FSSAI/2016
A | Raw Materials
(Common Tests) |
1. | Identification Test |
1.1 | By IR | ||
1.2 | By TLC | ||
1.3 | By Chemical | ||
2. | Arsenic | ||
3. | Iron | ||
4. | Chloride | ||
5. | Sulphate | ||
6. | Sulphated Ash | ||
7. | Loss on Drying | ||
8. | Melting range | ||
9. | Weight per ml | ||
10. | Acid Value | ||
11. | Saponification value | ||
12. | Heavy Metal as Lead | ||
13. | Water | ||
14. | Specification value | ||
15. | Clarity & color of solution | ||
16. | pH | ||
17. | Light Absorption | ||
18. | Solubility | ||
19. | Residual Solvent | ||
B | Raw Materials | ||
1. | Amlodipine Besilate IP | Assay by HPLC | |
2. | RS by HPLC | ||
3. | Amoxicillin Trihydrate | Assay by HPLC | |
4. | Ampicillin Trihydrate | Assay by HPLC | |
5. | Ascorbic Acid | Assay by titration | |
6. | Bromhexine Hydrochloride | Assay by Potentiometric titration | |
7. | Caffeine | Assay by Potentiometric titration | |
8. | Cefixime Trihydrate | Assay by HPLC | |
9. | Cetirizine Hydrochloride | Assay by Potentiometric titration | |
10. | Chlorpheniramine Maleate | Assay by Potentiometric titration | |
11. | Clotrimazole | Assay by titration | |
12. | Citric Acid Monohydrate | Assay by titration | |
13. | Diclofenac Sodium | Assay by Potentiometric titration | |
Related Substances by HPLC | |||
14. | Domperidone | Assay by titration | |
15. | Guiaphenesin | RS by HPLC | |
16. | Metformin HCI | Assay by titration | |
17. | Nicotinamide | Assay by titration | |
18. | Ofloxacin | Assay by titration | |
19. | Paracetamol | Assay by titration | |
20. | Povidone iodine | Assay by titration | |
21. | Pyridoxine HCI | Assay by titration | |
22. | Riboflavin | Assay | |
23. | Riboflavin sod. Phosphate | Assay | |
24. | Terbutaline | Assay by titration | |
RS by HPLC | |||
25. | Tinidazole | Assay by titration | |
26. | Zinc sulphate | Assay by titration | |
C | Finished Products (Common Test) | ||
1. | Average weight | ||
2. | Uniformity of weight/volume | ||
3. | Disintegration test | ||
4. | Water | ||
5. | pH | ||
D | Individual Formulations | ||
(i) | TABLETS | ||
1. | Aceclofenac Tablets | Assay By HPLC | |
2. | Amoxicillin Trihydrate Tablets | Assay By HPLC | |
3. | Atenolol Tablets | Assay By titration | |
4. | Albendazole Tablets | Assay By HPLC | |
5. | Allopurinol Tablets | Assay By UV | |
6. | Amoxycilin trihydrate and Potassium clavulanate Tablets | Amoxycillin Assay by HPLC | |
Potassium clavulanate Assay by HPLC | |||
7. | Ascorbic Acid Tablets | Assay by Titration | |
8. | Atorvastatin calcium Tablets IP | Assay by HPLC | |
RS by HPLC | |||
9. | Azithromycin Tablets | Assay by HPLC | |
RS by HPLC | |||
10. | Cefpodoxime proxetil Tablets | Assay by HPLC | |
11. | Chlorpromazine Tablets | Assay by UV | |
RS by TLC | |||
12. | Cetirizine Tablets | Assay by HPLC | |
13. | Co-trimoxazole Tablets | Trimethorprim Assay by UV | |
Sulphamethoxazole assay by Titration | |||
14. | Diclofenac Sodium Tablets | Assay by UV | |
15. | Enalparil maleate Tablets | Assay By HPLC | |
16. | Albendazole Tablets | Assay By HPLC | |
17. | Ferrous fumarate Tablets | Assay by Chemical analysis | |
18. | Folic acid Tablets | Assay By HPLC | |
19. | Hydrochlorothiazide and Losartan Potassium Tablets | Assay By HPLC | |
20. | Hydrochlorothiazide Tablets | Assay by UV | |
RS by TLC | |||
21. | Losartan potassium and Amlodipine Tablets | Assay By HPLC | |
22. | Losartan Potassium Tablets | Assay By HPLC | |
23. | Metformin HCl Tablets | Assay By UV | |
24. | Ofloxacin Tablets | Assay By HPLC | |
25. | Ondansterone HCl Tablets | Assay by HPLC | |
RS by HPLC | |||
26. | Ornidazole Tablets | Assay by Chemical analysis | |
RS by HPLC | |||
27. | Pantoperazole sustained release Tablets | Assay By HPLC | |
28. | Paracetamol Tablets | Assay By UV | |
29. | Rabeperazole sodium Tablets | Assay By HPLC | |
30. | Tinidazole Tablets | Assay By UV | |
31. | Zinc Sulphate Tablets | Assay by Titration | |
(ii) | CAPSULES | ||
1. | Amoxycillin Capsules | Assay By HPLC | |
2. | Ampicillin Capsules | Assay By HPLC | |
3. | Omeprazole Capsules | Assay By HPLC | |
4. | Fluoxetin HCl Capsules | Assay by HPLC | |
RS by HPLC | |||
(iii) | ORAL SUSPENSION / SYRUP / SOLUTION | ||
1. | Amoxicillin oral suspension | Assay By HPLC | |
2. | Azithromycin oral Suspension | Assay By HPLC | |
3. | Co-trimoxazole Oral suspension | Trimethorprim Assay by UV | |
Sulphamethoxazole assay by Photometric | |||
4. | Cefpodoxime proxetil oral suspension | Assay By HPLC | |
5. | Glycerin | Identification A by IR Acidity or alkalinity
Heavy Metals Iron Chloride Sulphate Aldehydes & reducing substances Ester (by titration) Ethylene glycol & RS Sugars Sulphated Ash Assay by titration |
|
6. | Hydrogen Peroxide Solution | Assay by Titration | |
7. | Metronidazole Benzoate Oral suspension | Assay potentiometrically | |
8. | Ondesteron syrup | Assay By HPLC | |
9. | Paracetamol syrup | Assay By HPLC | |
10. | Povidone Iodine ointment | Assay by Potentiometer | |
11. | Povidone Iodine Solution | Assay by Titration | |
(iv) | INJECTIONS | ||
1. | Amoxicillin injection | Assay By HPLC | |
2. | Cefuroxime sodium injection | Assay By HPLC | |
3. | Ceftriaxone sodium injection | Assay By HPLC | |
4. | Diclofenac sodium injection | Assay By HPLC | |
5. | Meropenem Injection | Sodium content by AAS | |
6. | Water for injection / Sterile water for injection | Acidity or alkalinity
Ammonium Calcium & magnesium Heavy metals Chlorides Nitrates Sulphates Aluminum |
|
(v) | CREAMS/OINTMENT/GEL | ||
1. | Clotrimazole cream | Assay By HPLC | |
(vi) | OPHTHALMIC PREPARATIONS | ||
1. | Ofloxacin Ophthalmic solution | Assay By HPLC | |
(vii) | POWDERS | ||
1. | Oral Rehydration Salts (ORS powder) | Assay of Total sodium by Flame photometer | |
Total potassium by Flame photometer | |||
Total chloride by titration | |||
Total citrate by titration | |||
Dextrose by Polarimeter | |||
2. | Purified / Raw/ Drinking Water Testing(Chemical) | Acidity or Alkalinity | |
Ammonium | |||
Calcium and Magnesium | |||
Heavy metals | |||
Chlorides | |||
Nitrates | |||
Sulphates | |||
Oxidisable substances | |||
Aluminum | |||
FOOD PRODUCTS | |||
1. | Biscuits | Moisture content | |
Acid insoluble ash | |||
Acidity of extracted fat as oleic acid | |||
2. | Dried Milk and Milk Products | Fat content | |
3. | Bakery Products | Moisture | |
Total solid content | |||
Total Ash | |||
Total Fat | |||
Acid Insoluble Ash | |||
Acidity of extracted fat as oleic acid | |||
Alcoholic Acidity as H2SO4 | |||
pH of the aqueous extract | |||
4. | Oil and Fats | Insoluble Impurities | |
Melting Point | |||
Acid value | |||
Saponification Value | |||
Iodine value | |||
Moisture | |||
Peroxide Value | |||
5. | Milk | Total Milk Solids | |
Titratable acidity as lactic acid | |||
Milk Fat | |||
Total ash | |||
Cane sugar | |||
Starch | |||
Urea | |||
Sodium chloride | |||
6. | Ghee | Moisture Content | |
Insoluble Impurities | |||
Acid value | |||
7. | Spices and other Condiments | Water Insoluble Ash | |
Total Ash on dry basis | |||
Alcohol soluble extract | |||
Cold water soluble extract | |||
Crude fiber (dry basis) | |||
Salt as Sodium Chloride | |||
Acid Insoluble Ash in dilute HCl on dry basis | |||
Turmeric Powder | Starch (on dry basis) | ||
8. | Ice Cream | Total Fat | |
Total solids | |||
Acidity as lactic acid |