ផលិតផលឱសថ

Pharmaceutical Products means any and all pharmaceutical products for human use, in any delivery method, dosage form or formulation, containing carfilzomib as an active pharmaceutical ingredient, whether as a sole active pharmaceutical ingredient or in combination with any other active pharmaceutical ingredient or ingredients. Sample 1 Based on 1 documents.

Examination of drug quality in each category of the
National Health Products Quality Control Center

1. ឱសថគ្រាប់ដូចជាៈ Coated, Uncoated, Chewable, Tablets, Capsules, Pills, Granules
   • Description / Appearance
   • Average Weight / Average Fill Weight
   • Uniformity of Weight
   • Disintegration / Dissolution
   • Hardness / Friability
   • Water Determination (Loss on Drying / Karl Fischer)
   • Microbial Limit Test / Microbial Contamination
   • Identification
   • Assay
   • Related Substances / Total impurity
   • Uniformity of Dosage Units (Weight Variation, Content Uniformity)
   • Heavy Metal
2. ឱសថ Suppositories, Pessaries
   • Description / Appearance
   • Average Weight / Average Fill Weight
   • Uniformity of Weight
   • Disintegration
   • Microbial Limit Test / Microbial Contamination
   • Identification
   • Assay
   • Related Substances / Total impurity
   • Uniformity of Dosage Units (Weight Variation, Content Uniformity)
   • Heavy Metal
3. ឱសថម៉្សៅប្រើតាមមាត់ដូចជា Oral liquid, Powder for Oral Suspension / Solution
   • Description / Appearance
   • Average fill Weight / Volume
   • Uniformity of Weight / Volume
   • pH
   • Specific gravity / Density / Weight per mL
   • Alcohol Content
   • Particle Size Distribution
   • Reconstitution Time
   • Microbial Limit Test / Microbial Contamination
   • Identification
   • Assay
   • Related Substances / Total impurity
   • Antimicrobial Preservative
   • Antioxidant Preservative Content
4. ឱសថម៉្សៅ ឬ Solution សម្រាប់ចាក់តាមសាច់ដុំ,​ សរសៃ ឬ​តាម​សរីរាង្គ​ខាងក្នុងដូចជា 
   • Description / Appearance
   • pH (Acidity / Alkalinity)
   • Particulate Matter
   • Extractable Volume / Weight
   • Functional Testing of Delivery System-control of Syringeability, Pressure and Seal integrity (Leakage Test)
   • Osmolality
   • Particle size distribution
   • Reconstitution time
   • Identification
   • Assay
   • Sterility Testing
   • Bacterial Endotoxin Test
   • Uniformity of dosage unit
   • Antimicrobial preservation
   • Antioxidant preservative content
5. ទឹកលាយឱសថ (Solvent)
   • Description / Appearance
   • pH (Acidity / Alkalinity)
   • Extractable Volume
   • Osmolality
   • Oxidizable Substance
   • Chloride Substance
   • Sulfate Substance
   • Calcium Substance
   • Magnesium Substance
   • Identification
   • Assay
   • Sterility Testing
6. វិភាគវត្ថុធាតុដើម Raw Material / Active Ingredient Substance
   • Description / Appearance
   • pH (Acidity / Alkalinity)
   • Water Determination (Loss on Drying / Karl Fischer)
   • Melting Point
   • Specific Optical Rotation
   • Residue on Ignition or Loss on Ignition
   • Ash Content
   • Identification
   • Assay
   • Purity Test (Heavy Metals, Related Substances)
7. ផលិតផល​ផ្សែងៗទៀតដែលត្រូវវិភាគបាក់តេរីសាស្ត្រ (Sterile and Non-Sterile Products)
   • Sterility Testing
   • Microbial Contamination