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RISHI BIOTECH
[BIO-IT SERVICES & RESEARCH COMPANY]
CHEMICAL TESTS
ICP -MS Analysis,Thermo Fischer,Scientific
Acidity and Alkalinity |
Ash Value/Sulphated Ash |
Assay |
GLC Assay (Normal) |
GLC(Head space) |
GLC Assay as per USP/BP |
System suitability (Additional) |
Extraction for finished product (Additional) |
Gravimetric assay |
HPLC Assay (UV Detector ) up to 30min run |
HPLC Assay (UV Detector ) up to 60min run |
HPLC as per USP/BP (UV Detector ) up to 30min run |
HPLC as per USP/BP (UV Detector ) up to 60min run |
Extraction for finish product ( Each) |
Infra Red Assay (Simethicone ) |
Microbiological Assay (Vitamins) |
Photofluormetric Assay (B1,B2) |
Titrimetric assay(LOD charges would be additional ,where |
required) |
UV/Vis. Spectrophotometer Assay |
UV/Vis. Spectrophotometer Assay( Additional extraction |
charges ) |
Bacterial Endotoxinial Test (LAL Test) |
Boiling point/range /Distilling Range |
Clarity and colour of solution |
Congealing Range /point |
Density (Bulk/Tap) |
Disintegration time (for Enteric Coated) |
Dissolution Test ( 06 Individual units ) |
UV/Vis.spectrophotrometric –Single stage--IP |
HPLC-isocratic –Single Stage- IP |
Element analysis |
AAS (each element /mineral) by flame technic |
AAS (each element /mineral) by MHS-15 Method |
Chemical method |
Ethanol content |
By Distillation |
By GC |
F1 Fatty Acid Composition –By GC |
Fatty Acid Composition (Up to 7) |
Fatty Acid Composition (Above 7) |
F2 Freezing Point |
I1 Identification Tests |
Identification by Chemical |
Identification by FTIR depends upon crushing time |
Identification by HPLC |
Melting point |
By TLC |
By UV/VIS. Spectrophotometer (complete spectrum) |
L1 Limit Tests |
By Chemical |
REV.03, 01-04-2012, MKT/LS/0 |
By AAS |
L2 Loss on Drying |
L3 Loss on Ignition |
M1 Melting point/range |
M2 Method Development |
M3 Method Validation as per BP/USP |
M4 Microbiological (Each count) |
Add. charge for,E.coli,salmonella, Pseudomonas, |
staphylococcus |
shigella |
M5 Minimum Inhibitory Concentration (per micro-organism) |
M6 Preservative Efficacy Test |
N1 Nutritional Supplement |
Carbohydrate, Fat content, Protein content, Moisture, |
Energy (in Kcal/Joules) |
O1 Optical/Specific Optical Rotation |
P1 Peroxide Value |
P2 pH Value |
R1 Refractive Index |
R2 Related Substances |
By GLC |
By HPLC (One Std and one test ) |
By TLC |
Related Substances with Impurity( GC,HPLC,TLC) |
S1 Saponification Value |
S2 Solubility Test |
S3 Sample Tested as per ISI |
Cosmetics |
Drinking water |
Mineral water |
S4 Stability Studies |
Long Term Testing |
30° + 2°C/ 65% RH + 5% Period 12 months. |
Frequency 0, 3, 6,9,12 months. One product- Three batches |
Accelerated Testing |
40° + 2°C/ 75% RH + 5% Period 6 months. |
Frequency 0, 3,6months. One product- Three batches |
S5 Sulphated Ash |
U1 Uniformity of Content |
UV/Colorimetric |
HPLC |
V1 Viscosity |
Brookfield Viscometer |
Ostwald Viscometer |
V2 Vitamin |
By Chemically (individual) |
Additional vitamins (each) |
By HPLC |
W1 Water content ( by KFR) |
W2 Weight per ml/ Relative Density |
W3 Raw material (IP/BP/USP without |
Micro,TLC,GC,HPLC,IR,Pyrogen & Toxicity) |
W4 Method validation by AAS depends upon no. of parameters |
W5 Method validation by HPLC depends upon no. of parameters |
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