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 | |||
