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Home » Injectable » Ranitidine Hydrochloride I.P.

Ranitidine Hydrochloride I.P.



Certificate of Analysis ( Ranitidine Hydrochloride I.P. )
No. Test Specification Result
1 Description White to Pale Yellow Crystalline Powder White Crystalline Powder
2 Solubility Freely Soluble in Water, Methanol and Ethanol (95%), Saparingly soluble in ethanol, very slightly soluble in Chloroform and in Dichloro Methane. Complies
3 Identification A. IR
B. Related Substances (TLC)
C. Chlorides (AS PER IP)
IR : Complies
TLC : Complies
Chlorides : Complies
4 Ph (1% w/v Soln in water) 4.5 to 6.0 5.10
5 Clarity & Colour of Solution 1.0% w/v solution is clear and not More intensely coloured than RS BY55 Complies
6 Related Substacne As Per IP Complies
7 Sulphated Ash Not more than 0.1% w/w 0.031%
8 Loss on Drying Not more then 0.75% w/w 0.15%
9 Assay / HPCL (Dry Basis) 97.5% to 102.0% 99.73%

Additional Tests
No. Test Specification Result
1 Melting Range 136 to 142 (Degree Centigrade) 140 C
2 Bulk Density 0.50 to 0.80 0.55 gm/cc

Certificate of Analysis ( Ranitidine Hydrochloride USP 27 / PH EUR IV )
No. Test Specification Result
USP 27 PH EUR IV
1 Description White off White, Odourless, Powder or Granules Almost White, Particularly Odourless, Powder
2 Solubility Freely Soluble In Water And Methanol Sparingly Soluble In Ethanol Complies
3 Identification IR, UV, TLC & Chlorides Complies
4 pH (1 in 100) 4.5 to 6.0 5.10
5 Appearance of Soln. As Per PH EUR III Complies
6 Related Substacne (TLC) Impurity B // A
Any Other Impurity
One Other Impurity
Two Other Impurity
Unidentified Impurity

Total Impurities
NMT 0.5%
NMT 0.3%
NMT 0.2%
NMT 0.1%
NMT .01%

NMT 1.0%
0.25%
0.20%
0.10%
0.05%
NIL

0.60%
7 Heavy Metals NMT 20 ppm Complies
8 Loss on Drying NMT 0.75% 0.15%
9 Sulphated Ash (Roi) NMT 0.01% 0.031%
10 Assay (Dry Basis) (97.5% - 102%) (98.5% - 101%) 99.73% // 99.50%
11 Organic Volatile Impurities (In Ppm) Chloroform
Benzene
1, 4 Dioxan
Methylene Chloride
Trichloroethylene
NMT 60
NMT 02
NMT 380
NMT 600
NMT 80
02
Nil
Nil
Nil
Nil

No. Test Specification Result
USP 27 PH EUR IV
1 * Residual Solvents ISO Propanol NMT 1500 ppm 1280
2 * Melting Range 136 to 142 (Degree Centigrade) 140
3 * Clarity : 10% Soln. Nm Absorbance /Transmission NMT 0.07 NLT 85% 0.04 / 91.3%
4 * Bulk Density (Gm/Cc) (Tapped) Powder 0.5 to 0.68
Granules 0.7 to 0.8
0.55
5 * Granulometry Test NLT 100% Passes Through 80// Passes (100% Through 80//)
6 * Extraneous Matter (As per Customer Specification)
1. Should not have any extraneous matter
2. Filter Paper should not be changed to black after filtration.
Complies

Complies
Note : (*) indicates the House Limits