SABINSA CORPORATION

FINISHED PRODUCT SPECIFICATION

Product Issue No. Supercedes Page Number
LACTOSPORE (15 BILLION/GM) 16 Issue No.15 dtd Page 1 of 2
11/02/2019
Prepared by Approved by Effective date
Nisha K N Dr.S Natarajan April 18, 2020
Documentation Officer Executive Vice President

Product code 1200

Product Type Probiotic
Strain Bacillus coagulans MTCC5856
Preparation type Fermentation
Standardization Bacillus coagulans viable spore count
Excipient used Maltodextrin
Excipient Name %Used CAS No.
Maltodextrin 85% to 90% 9050-36-6
Parameters Limit Reference
PHYSICAL
Description White to off white powder with Visual and Organoleptic
mild characteristic odor
Microscopy Complies USP <776>
Solubility Slightly soluble in water, insoluble in USP
methanol
Loss on drying Not more than 8.0% w/w (dried at USP <731>
105°C)
Lactic acid producing capacity Not less than 10ml of 0.05N NaOH is SLL/STP-L-015
consumed
Sieve Test (Passes Through) USP <786>
- 20 Mesh Not less than 100% w/w
- 40 Mesh Not less than 95% w/w
- 80 Mesh Not less than 90% w/w
CHEMICAL
Assay
Bacillus coagulans viable spore Not less than 15,000 million spores SLL/STP-B-014
count per gram
OTHERS
Lead Not more than 3ppm (µg/g) USP <2232>
Arsenic Not more than 1ppm (µg/g) USP <2232>
Cadmium Not more than 1ppm (µg/g) USP <2232>
Mercury Not more than 0.1ppm (µg/g) USP <2232>
MICROBIAL
Other aerobic microorganisms Not more than 0.1 Million cfu/g SLL/STP-O-009
Total yeasts and molds count Not more than 100cfu/g USP <2021>
Escherichia coli Negative/10g USP<2022>
Salmonella Negative/10g USP<2022>
Staphylococcus aureus Negative/10g USP<2022>
Pseudomonas aeruginosa Negative/10g USP <62>
 SABINSA CORPORATION

FINISHED PRODUCT SPECIFICATION

Product Issue No. Supercedes Page Number
LACTOSPORE (15 BILLION/GM) 16 Issue No.15 dtd Page 2 of 2
11/02/2019
Prepared by Approved by Effective date
Nisha K N Dr.S Natarajan April 18, 2020
Documentation Officer Executive Vice President

Parameters Limit Reference

Bile tolerant Gram negative bacteria Not more than 100cfu/g USP <2021>
Coliforms Less than 10cfu/g BAM 2001, 8th Edition, Chapter 4
ADDITIONAL INFORMATION
Sanitizing treatment Non-irradiated and not treated with ETO
Certification status (Kosher/Halal) Kosher certified , Halal certified
Genetic Modification Status Non-GMO Project Verified
BSE/TSE status BSE/TSE free
Country of origin India
Storage condition Store at room temperature
Shelf Life 3 Year(s)
Manufactured by Sami-Sabinsa Group Limited - Peenya
19/1, 19/2, I Main II Phase, Peenya Industrial Area, Bangalore. 560 058,
Karnataka, India

NAP:Not Applicable
NAV:Not Available