Erythritol BP Ph Eur USP NF Grade Manufacturers

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Erythritol BP Ph Eur USP NF Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Erythritol and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.

We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.

Synonyms: Erythritol
CAS Number: 149-32-6, Molecular Weight: 122.12, Chemical Formula: HOCH2[CH(OH)]2CH2OH, EINECS EC Number: 205-737-3, FEMA: ----,

Erythritol is a type of sugar alcohol. It has E number E968. Erythritol has the lowest calorie content of any sugar alcohol.

Specifications of Erythritol BP Ph Eur Grade:
C4H10O4 --- 122.1 --- CAS 149-32-6
Action and use: Excipient.

DEFINITION
(2R,3S)-Butane-1,2,3,4-tetrol (meso-erythritol).
Content: 96.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, crystalline powder or free-flowing granules.
Solubility: Freely soluble in water, very slightly soluble in ethanol (96 per cent).

IDENTIFICATION
A. Melting point: 119C to 122C.
B. Infrared absorption spectrophotometry.

TESTS
Appearance of solution: The solution is clear and colourless.
Dissolve 5.0 in water and dilute to 50 mL with the same solvent.
Conductivity: Maximum 20 microS⋅cm-1.
Dissolve 20.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100.0 mL with the same solvent. Measure the conductivity of the solution, while gently stirring with a magnetic stirrer.
Related substances: To pass the test.
Limits:
— any impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);
— total: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);
— disregard limit: area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).
Lead: Maximum 0.5 ppm.
Water: Maximum 0.5 per cent, determined on 1.00 g.
Microbial contamination:
If intended for use in the manufacture of parenteral preparations:
— TAMC: acceptance criterion 100 CFU/g.
If not intended for use in the manufacture of parenteral preparations:
— TAMC: acceptance criterion 1000 CFU/g;
— TYMC: acceptance criterion 100 CFU/g;
— absence of Escherichia coli;
— absence of Salmonella.
Bacterial endotoxins:
If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins:
— less than 4 IU/g for parenteral preparations having a concentration of 100 g/L or less of erythritol;
— less than 2.5 IU/g for parenteral preparations having a concentration of more than 100 g/L of erythritol.

Specifications of Erythritol USP NF Grade:
C4H10O4 --- 122.12
1,2,3,4-Butanetetrol
Butane 1,2,3,4-tetrol (meso-erythritol) --- CAS 149-32-6.

DEFINITION
Erythritol is obtained by fermentation of starch enzyme hydrolysate (from starches such as wheat and corn). It is obtained from the fermentation broth of suitable osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachiliensis. It contains NLT 96.0% and NMT 102.0% of erythritol (C4H10O4), calculated on the anhydrous basis.

IDENTIFICATION
A. Infrared Absorption.
B. Melting Range or Temperature: 119C to 123C

Assay: Acceptance criteria: 96.0% to 102.0% on the anhydrous basis
Residue on Ignition: NMT 0.1%
Limit of Lead: To pass the test Acceptance criteria: NMT 0.5 micro-gm/g
Related Compounds:
Individual impurities: NMT 2.0%
Total impurities: NMT 2.0%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count using the Plate-Count Methods is NMT 1000 cfu/g, and the total combined molds and yeasts count is NMT 100 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Loss on Drying: Dry the Sample at 105C for 4 h. Acceptance criteria: NMT 0.2%.
Water Determination: NMT 0.5%
Conductivity: Acceptance criteria: NMT 20 microS/cm
Packaging and Storage: Preserve in well-closed containers. Store at room temperature.

Keywords: Erythritol IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 149-32-6 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.

Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.

All products are Sold for Industrial and Laboratory Use only. No other use is permitted.