Drugs & Pharmaceuticals Testing
Any pharmaceutical product manufacturer requires a quality control which is one of the Pre- requisite to regulatory compliances. Affinitee Laboratories Pvt Ltd provides expert analytical services in all the areas of testing starting from raw materials, excipients, APIs, Bulk drugs, intermediates to finished products. Our sophisticated pharmaceutical testing lab operates as an extension of your QC and Analytical R&D laboratories.
Data Integrity is the most essential part in our lab. The same is being handled in 21 CFR compliance software- Waters Empower 3, TC Navigator and Lab solution. All data acquisition systems are linked through server security from generation till archival of electronic data. The lab is well equipped to conduct all sorts of tests as per IP, BP, USP, and EP, NF or In-house tests methods. The lab is equipped with latest instruments like.
We offer a range of services for
early phase and late phase studies, including:
- Appearance
- Solubility
- Clarity & Color of solution
- LOD
- Water by KF
- pH/ acidity/ alkalinity
- Sulphated ash/ residue on ignition/ loss on ignition
- Melting point/ Boiling point
- Boiling range
- Optical rotation
- Density/ specific gravity at 25 C
- Gravimetric assay
- Congealing range
- Freezing point
- Jelly strength
- Peroxide value
- Refractive index
- Acid value
- Iodine value
- Hydroxyl value
- Saponification value
- Pepsin
- Papain
- Fungal diastase
- K value
- Crystallinity
- Ether soluble substances
- Degree of substitution
- Fat content
- Total residue
- Total dye content
- Degree of polymerization
- Protein content
- Carbohydrate content
- Energy value
- Identification (by IR, HPLC, UV, GC, TLC, Chemically)
- Limit test (Arsenic, Chloride, heavy metals, iron, lead, sulphate)
- Viscosity
- Assay (Titration, HPLC, GC, AAS, etc)
- Related substances
- Flame photometer
- Tablets (Coated and Uncoated)
- Capsules (soft and hard gelatine)
- Powders (Eg. ORS powders)
- Creams
- Ointments/ Gum paints
- Gels
- Pastes
- Disinfectants
- Detergents
- Mouth wash
- Injections (Dry and liquid)
- Ears/ Eye Drops
- Syrups
- Oral Suspensions
- Disintegration test
- Dissolution rate test (HPLC, AAS, GC)
- Uniformity of weight/ mass/ volume/ fill
- Uniformity of content
- Friability test
- Hardness test
- pH/ acidity/ alkalinity
- Density
- Pepsin
- Papain
- Fungal diabase
- Assay as per IP/ BP/ USP (HPLC, GC, UV, FTIR)
- Related substances (HPLC, GC)
- Residual solvents (by GC)
CHEMICAL
TEST PARAMETER
GENERAL PHYSICAL/ CHEMICAL TESTS
- CHEMICAL TESTS
- Appearance
- Disintegration Test
- Uncoated tablet
- Coated tablet
- Enteric coated tablet
- Hardness Test
- Clarity & color of solution
- Loss on Drying
- Water by K.F
pH/Acidity/Alkalinity - Sulphated ash/residue on ignition/Loss on ignition
- Melting point/Boiling point
- Boiling range
- Optical rotation
- Density /specific gravity at 25°C
- Uniformity of wt.(10 tab)
- Gravimetric Assay
- Congealing range
- Density
- Freezing point
- Jelly strength
- Peroxide value
- Refractive index
- Acid value Iodine value, Hydroxyl value, saponification value (Each)
- Pepsin
- Papain
- Fungal diastase
- Serratiopeptidase
- K-Value
- Crystallinity
- Sorbitol by TLC/Chemical
- Flame photometer(Each Element)
- Chemical method( Each Element)
- Ether soluble substance
- Degree of substitution
- Fat Content
- Total Residue
- Thermal Stability
- Total Dye Content
- Active Detergent
- Sulphur Dioxide
- Degree of Polymerization
- Hydrocarbon
- Aluminium by Fluorimetry
- Protein Content
- Carbohyrate Content
- Energy Value
- Limit of Fluoride
IDENTIFICATION TESTS
- By Chemical
- By FTIR (Raw Material)
- By FTIR (Finished Product)
- Weight balance capacity (200 gms)LCGC
- Horizontal autoclaveNaresh brothers
- By HPLC (Single injection for each solution)
- By UV/VIS Spectrophotometer (Complete Spectrum)
- By UV/VIS Spectrophotometer (Single Wave length)
- By GC as per IP/BP/USP (Single injection for each solution)
- By Paper Chromatography (For each column)
LIMIT TEST
- Arsenic (Chemical method)
- Chloride
- Free Formaldehyde
- Heavy Metals
- Iron
- Lead
- Sulphate
- Any Metal as per BP/USP ( By AAS)
VISCOSITY
- Fungi lab Viscometer (Dynamic viscosity)
- Ostwald Viscometer
- Complete Analysis of Cream as per ISI
- Hair Oil, Lipstick & Tooth paste, Shaving cream as per ISI
- Method validation As per ICH & USP
TITRIMETRIC ANALYSIS
- Titrimetric Assay
- Uniformity of Content
