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Calcium Saccharate CDMF PARENTEX 1KG
P3483SR10040550C306DW
CDMF PARENTEX40550C3
5793-89-593885
C6H8CaO8.4H2OApril 2023
320.26March 2026
Sr.No.TestResultSpecification
1DescriptionWhite, odorless, tasteless crystalline powder.White, odorless ,tasteless crystalline powder.
2SolubilityCompliesFreely soluble in dilute hydrochloric acid or dilute nitric acid; slightly soluble in boiling water; very slightly soluble in cold water; insoluble in ethanol, ether, or chloroform.
3Identification A (Calcium)CompliesA white precipitate, which is insoluble in 6N acetic acid but soluble in hydrochloric acid should form.
4Identification B (By IR)CompliesIR spectra of the sample should be concomitant with IR spectra of the corresponding standard.
5Assay99.8%99.0% w/w - 101.0% w/w
6Chloride (Cl)Less than 0.07%NMT 0.07%
7SulfateLess than 0.12%NMT 0.12%
8Sucrose and reducing sugarsCompliesNo red precipitate should form immediately
9Optical Rotation+20.9°+17.5° to + 21.5°
10Heavy metalsLess than 10ppmNMT 10ppm
11Total aerobic microbial countLess than 1000 CFU/gmNMT 1000 CFU/gm
12Total Yeast and mold countLess than 100 CFU/gmNMT 100 CFU/gm
13E.coliAbsent/gmshould be absent/gm
14Bacterial endotoxinsLess than 5 EU/gmNMT 5 EU/gm (For in-house control only, not for release & shelf life)
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, CP SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
Tested By
(Chemist - Quality Control)
Approved By
(Head - Quality Control)
Computer Generated Report - Does not require Signature.
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