Laboratory Testing Values
The laboratory testing values expressed in points, conducted by the Official Medicines Control Laboratory Division (OMCL), are listed below.
The prices for quality control of medicinal products conducted by the Agency are listed in part 6 of HALMED's fees, or here.
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 |