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Specification Of Rosuvastatin Calcium
| Test | Specification |
| Description | A White To Creamish Colour Powder. |
| Solubility | Soluble In 100 Parts Of N,N-Dimethyl Formamide |
| Identification A) By I.R. B)By HPLC |
I.R. Spectrum Should Be Identical To That Of Standard Retention Time Of The Sample Peak Should Corresponds To That Of Standard |
| Water By K.F. (In DMF) | NMT 8.0%W/W |
| Calcium Content | 3.0% - 5.0%W/W |
| Related Substances (By HPLC) A) Max. Single Impurity B) Total Impurities |
NMT 1.0% NMT 2.0% |
| Assay (HPLC,OAB) | NLT 97% W/W |
| Test | Specification |
| Characteristics | White Crystalline powder |
| Identification | A,B,C,D E as per B.P. |
| Solubility | Soluble in water Methanol |
| Melting Point | 210oc to 218oc |
| pH | 1.2 to 1.8 |
| Heavy Metals | Not more than 20 ppm |
| Sulphated Ash | Not more than 0.2% |
| Loss On Drying | Not more than 0.5% |
| Related impurities [By TLC] | Spot of Ref. Material |
| Assay On Dried Basis | Between NLT 99.0 % to NMT 100.5% |
|
TEST |
SPECIFICATION AS PER USP |
|
Description |
A clear colourless solution |
|
Identification (A) HPLC (B) Colour reaction (C) Colour reaction |
To comply as per BP A green colour should be produced A red colour should be produced |
|
Average Volume of 10 containers |
NLT 1.0 ml |
|
Colour and Clarity |
Clear and colorless solution |
|
pH |
2.8 to 3.6 |
|
Sterility testing |
To be Sterile |
|
Volume Variation |
NLT 1.0 ml |
|
Noradrenaline |
NMT 1.0 % |
|
Particulate Matter |
Sample should be free from particles |
|
Assay: Each ml contains: Epinephrine Acid Tartarate Eq to Epinephrine BP 1mg |
90.0% to 110.0% |
Sanjay (Yashica Pharmaceuticals Private Limited)
No. 11/12, Shubham Apartment, Syndicate Kalyan West, Thane, Maharashtra - 421301, India
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