No |
Test |
Points |
1 |
Appearance |
15 |
2 |
pH measurement |
57 |
3 |
Relative density measurement |
107 |
4 |
Mass variation for tablets/pessaries/vaginal tablets/single dose from multi-dose containers |
45 |
5 |
Tablet friability, thickness and hardness tests |
39 |
6 |
Colour of solution |
60 |
7 |
Clarity of solution |
44 |
8 |
Test for extractable volume of parenteral preparations |
126 |
9 |
Disintegration test of tablets, capsules, vaginal tablets, pessaries and suppositories |
38 |
10 |
Disintegration test of gastro-resistant tablets |
72 |
11 |
Refraction index measurement |
123 |
12 |
Conductivity measurement |
37 |
13 |
Optical rotation measurement |
112 |
14 |
Viscosity measurement |
231 |
15 |
Loss on drying |
55 |
16 |
Loss on drying in vacuum |
82 |
17 |
Osmolality test |
123 |
18 |
Titrimetric content determination |
303 |
19 |
Kjeldahl protein determination |
429 |
20 |
KF water determination |
400 |
21 |
Identification based on chemical reaction |
82 |
22 |
Purity test - Limit test |
107 |
23 |
Identification by IR method |
255 |
24 |
Identification by TLC method |
271 |
25 |
Determination of related substances by TLC method |
445 |
26 |
Identification and content determination by HPLC method |
867 |
27 |
Identification and content determination of two active substances by same HPLC method |
997 |
28 |
Impurity determination by HPLC method |
986 |
29 |
Impurity determination of two active substances by same HPLC method |
1168 |
30 |
Content uniformity by HPLC method |
1022 |
31 |
Content uniformity of two active substances by same HPLC method |
1207 |
32 |
Dissolution of active substance by HPLC method |
1202 |
33 |
Dissolution of two active substances by same HPLC method |
1318 |
34 |
Gastro-resistance test and dissolution of active substance by HPLC method |
1320 |
35 |
Modified release dissolution testing of active substance by HPLC method |
1696 |
36 |
Identification, content determination and content uniformity by same HPLC method |
1203 |
37 |
Identification, content and impurity determination by same HPLC method |
1293 |
38 |
Identification, content, content uniformity and impurity determination by same HPLC |
1859 |
39 |
Identification and content determination by GC method - residual solvents |
856 |
40 |
Identification and content determination by GC method |
874 |
41 |
Dissolution of active substance by GC method |
1170 |
42 |
Identification by UV method |
127 |
43 |
Content determination by UV method |
266 |
44 |
Content uniformity by UV method |
403 |
45 |
Dissolution testing by UV method |
728 |
46 |
Modified release dissolution testing by UV method |
939 |
47 |
Sterility testing |
546 |
48 |
Microbial contamination test |
399 |
49 |
Bacterial endotoxin determination, LAL test by "GEL-CLOT" method |
348 |
50 |
Quantitative determination of HBsAg antibodies |
424 |
51 |
Determination of protein composition by cellulose acetate electrophoresis |
351 |
52 |
Determination of coagulation factor VIII potency by chromogenic assay |
890 |
53 |
Identification procedure and HBsAg content determination in vaccine |
469 |
54 |
Identification of human proteins and animal immuno-sera for human use by immune-electrophoresis |
500 |
55 |
Non-activated partial thromboplastin time - NAPTT for FIX |
506 |
56 |
Determination of ristocein cofactor activity by agglutination method - vWF |
460 |
57 |
Determination of hem in human albumins |
39 |
58 |
Determination of coagulation factor values FIX |
599 |
59 |
Determination of pre-kallikrein activator activity in samples of human albumin |
523 |
60 |
Determination of Anti-D antibody titres in human immunoglobulin |
247 |
61 |
Determination of IgA content in human immunoglobulin |
254 |
62 |
Potency and stability testing of viral vaccines (rubella component) |
817 |
63 |
Potency and stability testing of viral vaccines (measles component) |
776 |
64 |
Bitterness value test - herbal drugs |
113 |
65 |
Swelling index - herbal drugs |
35 |
66 |
Dry extract and extract loss on drying - herbal drugs |
72 |
67 |
Macroscopic and microscopic identification of herbal drugs - tea mixtures |
257 |
68 |
Quantitative determination of Anti-tetanus antibodies |
458 |
69 |
Test for pyrogenic substances |
253 |
70 |
Anti-A and anti-B haemaglutinin determination |
367 |
71 |
Friability determination of tablets |
30 |
72 |
Total ash determination |
50 |
73 |
Active substance content determination by TLC method |
543 |
74 |
Turbidimetric determination of solution clarity |
129 |
75 |
Determination of bacterial endotoxins - kinetic turbidimetric method |
206 |
76 |
Determination of bacterial endotoxins - kinetic chromogenic method |
192 |
77 |
Assay by FAAS method |
449 |
78 |
Moisture determination by halogen moisture analyzer |
95 |
79 |
Determination of chlorides by potentiometric titration |
211 |