| I | Test and assay of Drugs requiring use of animals - |
|---|
| 1 | Pyrogen test |
| 2 | Abnormal or undue toxicity or safety test |
| 3 | Skin sensitivity/Eye irritancy test /Dermal toxicity |
| 4 | Heparin Identification |
| II | Microbiological tests and assays - |
|---|
| 1 | Bioassay of Antibiotic |
| 2 | Microbiological assay of antibiotics, vitamins and amino acids |
| 3 | Phenol coefficient for black disinfectant fluids |
| 4 | Sterility test – Parenteral preparations, Surgical dressings, Syringes and needles,
Transfusion and infusion sets or assemblies, Intra ocular lens, I.V. Canula, |
| 5 | Bacterial Endotoxin |
| 6 | Microbial limit test |
| III | Identification tests - |
|---|
| 1 | Chemical |
| 2 | Microscopy |
| 3 | IR Spectroscopy |
| 4 | UV Spectroscopy |
| 5 | Chromatography |
| | A | Thin layer Chromatography |
| | B | Gas Chromatography |
| | C | High Performance Liquid Chromatography |
| | D | High Performance Thin Layer Chromatography |
| IV | Physical / Chemicals tests and determinations - |
|---|
| 1 | Absorbency |
| 2 | Acid value |
| 3 | Adhesive strength |
| 4 | Alcohol content |
| 5 | Ash |
| 6 | Diagnostic –aids : Uri strip (Estimation of Glucose, Protein and pH) |
| 7 | Disintegration tests |
| 8 | Dissolution test |
| 9 | Extractable volume |
| 10 | Extractive value |
| 11 | Fluorescence. |
| 12 | Foreign matter |
| 13 | Iodine value |
| 14 | Limit test for Arsenic |
| 15 | Limit test for Heavy metals |
| 16 | Limit test for impurities/ Controlled degradation |
| 17 | Loss on drying |
| 18 | Melting point |
| 19 | Needle attachment - Sutures |
| 20 | Net content |
| 21 | Optical rotation & Specific Optical rotation |
| 22 | Particle size and count |
| 23 | Particulate matter –Parenterals |
| 24 | Peroxide value |
| 25 | pH value |
| 26 | Physical requirement test of set, syringe, needles |
| 27 | Refractive index |
| 28 | Related substances |
| 29 | Saponification value |
| 30 | Solubility |
| 31 | Soluble extractives |
| 32 | Specific gravity |
| 33 | Sulphated ash |
| 34 | Tensile strength |
| 35 | Thread count |
| 36 | Total solids |
| 37 | Uniformity of content. |
| 38 | Uniformity of dispersion |
| 39 | Uniformity of weight |
| 40 | Unsaponifiale matter |
| 41 | Viscosity |
| 42 | Volatile oil |
| 43 | Water (Karl Fisher) |
| 44 | Weight /unit area (surgical) |
| 45 | Weight per ml |
| V | Assays - |
|---|
| 1 | General chemical methods |
| 2 | Non-aqueous/instrumental |
| 3 | Chromatography – HPLC, GC , HPTLC, AAS, Flame photometry, IR |
| VI | Sera and Vaccine - |
|---|
| 1 | Sterility test | |
| 2 | Testing of antisera for the specific titre |
| VII | Rubber condoms –(Schedule -R) |
|---|
| 1 | Dimensions |
| 2 | Water leakage test |
| 3 | Burst volume and burst pressure test |