Laboratory Testing Values
The laboratory testing values expressed in points, conducted by the Official Medicines Control Laboratory Division (OMCL), are listed below. The price of a point is HRK 7.00 or EUR 0.93.
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 |