Product Data

Rev.No.4/2448/11360

Print date 07-Nov-2022

GLUCONAL® CAM-P-OR

Description GLUCONAL CAM-P is the monohydrate calcium salt of gluconic acid. It is an odorless and practically
tasteless white powder. GLUCONAL CAM-P-OR can be readily formulated into capsules, tablets and
liquids as therapeutic or nutritional supplement.
It is not intended for use in the preparation of injectable dosages.

Specification Product calcium gluconate

Hydrate form mono
Form powder

Assay Assay 98.5-102.0 % (w/w)1)

Assay calcium 8.8-9.1 % (w/w)4)

Visual sensory Clarity (EP-method) n.m.t. susp II 2)

characteristics Color fresh (powder) white
Color n.m.t. Y6 2)

Identification Positive test for calcium passes test EU/USP

Positive test for gluconate passes test EP/USP

Purity Loss on drying max. 1.0 % (w/w)1)

Magnesium and alkali salts max. 0.4 % (w/w)2)
Chlorides max. 200 ppm3)
Sulfate max. 100 ppm3)
Heavy metals, as Pb max. 10 (heavy metals total) ppm1)
Arsenic (as As) max. 3 ppm1)
Lead max. 0.5 ppm1)
Reducing substances max. 1.0% 1)
Sucrose and/or reducing sugars passes test EP 2)
Organic impurities and boric acid passes test EP 2)

Microbiology Microbial contamination: TAMC max. 1000 CFU/g

Microbial contamination: TYMC max. 50 CFU/g
Enterobacteriaceae absent in 1 g 5)
Salmonella absent in 50 g

Physical-chemical- Molecular formula C H CaO -H O

12 22 14 2

properties Molecular weight 448.4

Chemical name D-gluconic acid calcium salt 2:1

Regulatory / Registration CAS number 18016-24-5

EEC Additive number E578 Calcium gluconate
GRAS status 21CFR184.1199
Complies with USP/EP

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Wed Jan 10 12:43:20 COT 2024

Maria Camargo
 Product Data
Rev.No.4/2448/11360

Print date 07-Nov-2022

GLUCONAL® CAM-P-OR

1)
Method of analysis according to USP and EP
2)
Method of analysis according to EP
3)
Meets the narrowest specifications EP
4)
Calculated from assay on as is basis
5)
Method of analysis available upon request

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