About HALMED

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
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