Annex (1)
To the Accreditation Certificate No.
JAS Test - 041 Dated
2009-10-01
for the Sana
pharmaceutical Research Co. Laboratory/ Amman
Scope of Accreditation
Physical and Chemical Tests of Raw Materials, Pharmacetical
Products,
Cosmatic Products and Food Products
|
Tested Parameter/ |
Test Methods/Standards |
|
Assay of drug content (Assay) by HPLC for raw materials, and pharmaceutical products |
§ SPR-SOP031R0 Testing methods for drug content (Assay) by using HPLC. § USP <621> Cromatography § Ph. Eur. method 2.2.29 Liquid Chromatography |
|
Assay of active ingredient by spectrophotometer for raw materials, and pharmaceutical products |
§ SPR-SOP044R0 General procedure for testing drug assay or drug release by spectrophotometer. § USP <851> Spectrophotometry and light scattaring § Ph. Eur. method 2.2.25 Ultraviolet and Visible Absorption Spectrophotometry |
|
Assay of active ingredient by titration for raw materials and pharmaceutical products |
§ SPR-SOP039R0 General procedure for testing drug assay by titration method. § USP <541> Titrimetry. § BP 2007: Appendix I B. Volumetric Reagents and Solutions. |
|
Dissolution of active ingredients by HPLC for pharmaceutical products |
§ SPR-SOP041R0 general method for drug release (dissolution) by using HPLC. § USP <711> Dissolution § USP <621> Cromatography § Ph. Eur. method 2.9.3 Dissolution Test for Tablets and Capsules (Dissolution Test for Solid Dosage § Ph. Eur. method 2.2.29 Liquid Chromatography |
|
Disssolution of active ingredients by spectrophotometer pharmaceutical products |
§ SPR-SOP044R0 General procedure for testing drug assay or drug release by spectrophotometer. § USP <711> Dissolution § Ph. Eur. method 2.9.3 Dissolution Test for Tablets and Capsules (Dissolution Test for Solid Dosage § USP <851> Spectrophotometry and light scattaring § (Ph. Eur. method 2.2.25) Ultraviolet and Visible Absorption Spectrophotometry. |
|
Related substance test of compendial raw materials and compendial pharmaceutical products by HPLC method |
§ SPR-SOP042R0 General procedure for total impurities and individual impurities calculations by HPLC. § USP <621> Cromatography § Ph. Eur. method 2.2.29 Liquid Chromatography § ICH Guidelines Q3A R2 § ICH Guidelines Q3B R2 |
|
Related substance test of compendial raw materials and compendial pharmaceutical products by TLC method |
§ SPR-SOP043R0 General procedure for total impurities and individual impurities measurement by TLC § USP <621> Cromatography § Ph. Eur. method 2.2.2 Thin-layer Chromatography § ICH Guidelines Q3A R2 § ICH Guidelines Q3B R2 |
|
Particle size analysis for raw materials or intermediate products using miroscope and digital camera. |
§ SPR-SOP045R0 General procedures for particle size analysis by microscope § USP <776> Optical Microscopy |
|
Particle size analysis for raw materials or intermediate products using sieve analysis procedure. |
§ SPR-SOP034R0 General procedure for particle size analysis by seive method. § USP <786> Particle Size Distribution Estimation By Analytical Sieving |
|
Water content test for raw materials, pharmaceutical products, cosmetic products and food products by Karl-fisher memotitrator |
§ SPR-SOP038R0 General procedures for water content testing. § USP <921> Water Determination |
|
Description test raw materials, pharmaceutical products, cosmetic products and food products |
§ SPR-SOP032R0 Physical testing.
|
|
Hardness test for tablets |
§ SPR-SOP032R0 Physical testing. § USP <1217> Tablet Breaking Force |
|
Disintigration test for tablets and capsules |
§ SPR-SOP032R0 Physical testing. § USP <701> Disintegration § Ph. Eur. method 2.9.1 Disintegration Test for Tablets and Capsules |
|
pH test for raw materials, pharmaceutical products, cosmetic products and food products. |
§ SPR-SOP033R0 General method for pH measurement). § USP <791> pH |
|
Friability test for tablets |
§ SPR-SOP032R0 Physical testing. § USP <1216> Tablet Friability § Ph. Eur. method 2.9.7 Friability of Uncoated Tablets |
|
Liquid density for raw materials, pharmaceutical products, cosmetic products and food products. |
§ SPR-SOP037R0 General procedures for Liquid density calculation. § USP <841> Specific gravity § Ph. Eur. method 2.2.5 Determination of Weight per Millilitre, Density, Relative Density and Apparent Density. |
|
Weight Uniformity for pharmaceutical dosage units. |
§ SPR-SOP032R0 Physical testing. § Ph. Eur. method 2.9.5 Uniformity of Weight (Mass) § USP <905> Uniformity Of Dosage Units |
|
Content Uniformity for pharmaceutical dosage units. |
§ SPR-SOP040R0 General procedures for Content uniformity testing by chemical method. § USP <905> Uniformity Of Dosage Units § Ph. Eur. Method 2.9.40 Uniformity of Dosage Units |
List of employees in the laboratory who are technically responsible for issuing the test reports in the scope of accreditation:1- Quality Manager / Dr. Raed M. Salah.