RanQ Pharmaceuticals & Excipients Pvt. Ltd.

   
Product Specification
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Product Specifications

MICROCRYSTALLINE CELLULOSE
Product Name RANCEL™ - Micro Crystalline Cellulose
Description A White, odorless, tasteless, granular
free flowing powder
Identification test A,B (USP-NF) Conforms
Identification test C (USP-NF) degree of polymerisation; max 350
Solubility (Ph Eur.) meets requirements
Conductivity max 75 m
pH 5.00 - 7.00
Loss on drying max. 6.0 %
Residue on ignition :
max 0.05%
Ether soluble substances :
max 0.05%
Water soluble substances :
max 0.20%
Heavy metals :
max 10 ppm
Particle size & Bulk Density :
As per grades enumerated in the
Grades section
Standard plate count :
max 100 /g
Yeasts :
max 10/g
Moulds :
max 10/g
E.coli :
neg. in 10g
Ps.aeruginosa :
neg. in 10g
St. aureus :
neg in 10g
Salmonella sp. :
neg. in 10g
   

SODIUM STARCH GLYCOLLATE
Product Name :
RANJEL™ Sodium Starch Glycollate
Description :
A white fine , free flowing odourless
powder
Solubility :
As per Ph. Eur
Identification :
As per Ph. Eur
PH :
5.5 to 7.5
Heavy metals :
NMT 20 ppm
Iron :
NMT 20 ppm
Loss on drying :
NMT 10.0 % w/w
Sodium Chloride :
NMT 7.0 % w/w
Sodium Glycollate :
NMT 2.0 % w/w
Sodium Assay :
2.8% w/w to 4.2% w/w
Particle size :
Retained on 60 mesh
Swelling capacity :
16 to 38 ml /gm
Hydration Capacity :
NLT 15
Microbiological limits
Salmonella :
E.coli :
-
As per Ph.Eur
As per Ph.Eur
 
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