  |
|||
Search for the supplies that you need here:
DMF Support and Documentations Available |
|||
 WHO-GMP Certified Good Manufacturing Practice Certified by World Health Organization |
 WC, Written Confirmation for Active Substance to be imported into European Union (EU). |
||
------ 
Maltitol Powder Liquid Solution USP BP Ph Eur FCC Food Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Maltitol Powder Liquid Solution 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.
All technical documents and DMF support available.
Maltitol Powder Liquid Solution SDS of Manufacturers
Synonyms: Maltitol Powder Liquid Solution
CAS Number: 585-88-6, Molecular Weight: 344.31, Chemical Formula: C12H24O11, EINECS EC Number: 209-567-0, FEMA: ----,
Maltitol is a sugar alcohol is commonly used in low-carb or “sugar-free” products such as candy and nutrition bars. These sweeteners are similar to sugar in terms of taste, texture, and interaction with other ingredients. It has an E number of E965.
Specifications of Maltitol USP NF Grade:
C12H24O11 --- 344.31
d-Glucopyranosyl-d-glucitol --- [CAS 585-88-6].
DEFINITION
Maltitol contains NLT 92.0% and NMT 100.5% of d-maltitol (C12H24O11 ), calculated on the anhydrous basis. The amounts of total sugars, other polyhydric alcohols, and any polyol anhydrides, if detected, are not included in the requirements or in the calculated amount in General Notices and Requirements, 5.60.10 Other Impurities in USP and NF Articles.
IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
To pass the test by Chromatography
Acceptance criteria: 92.0%–100.5% on the anhydrous basis
Limit of Nickel:
To pass the test
Acceptance criteria: NMT 1 micro-g/g
Reducing Sugars:
Acceptance criteria: To pass the test corresponding to NMT 0.3% of reducing sugars, as glucose.
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count using the Plate Method does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g.
Conductivity:
To pass the test
Acceptance criteria: NMT 20 µS/cm
Water Determination: NMT 1.0%
Packaging and Storage: Preserve in well-closed containers. No storage requirements are specified.
Specifications of Maltitol Solution USP NF Grade:
DEFINITION
Maltitol Solution is a water solution containing, on the anhydrous basis, NLT 50.0% of d-maltitol (C12H24O11 ) (w/w) and NMT 8.0% of d-sorbitol (C6H14O6 ) (w/w). The amounts of total sugars, other polyhydric alcohols, and any polyol anhydrides, if detected, are not included in the requirements nor in the calculated amount under Other Impurities.
IDENTIFICATION
A. Procedure
Sample: 1.4 g of Maltitol Solution
Analysis: Dissolve the Sample in 75 mL of water. Transfer 3 mL of this solution to a 15-cm test tube, add 3 mL of freshly prepared catechol (1 in 10), and mix. Add 6 mL of sulfuric acid, and mix. Gently heat the tube in a flame for about 30 s.
Acceptance criteria: A deep pink or wine-red color appears.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. Limit of Diethylene Glycol and Ethylene Glycol:
To pass the test by Chromatography
Acceptance criteria
Diethylene glycol: The peak area ratio of diethylene glycol to the internal standard in the Sample solution is NMT the peak area ratio of diethylene glycol to the internal standard in the Standard solution, corresponding to NMT 0.10% of diethylene glycol in Maltitol Solution.
Ethylene glycol: The peak area ratio of ethylene glycol to the internal standard in the Sample solution is NMT the peak area ratio of ethylene glycol to the internal standard in the Standard solution, corresponding to NMT 0.10% of ethylene glycol in Maltitol Solution.
ASSAY
To pass the test by Chromatography
Acceptance criteria: NLT 50.0% of d-maltitol (w/w) and NMT 8.0% of d-sorbitol (w/w), on the anhydrous basis
Residue on Ignition: NMT 0.1%, calculated on the anhydrous basis, determined on a 2-g portion
Limit of Nickel:
To pass the test
Acceptance criteria: NMT 1 ppm, calculated on the anhydrous basis
Reducing Sugars:
Acceptance criteria: To pass the test corresponding to NMT 0.3% of reducing sugars, on the anhydrous basis, as glucose.
Microbial Enumeration Tests and Tests for Specific Microorganisms: The total aerobic microbial count using the Plate Method is NMT 1000 cfu/mL, and the total combined molds and yeasts count is NMT 100 cfu/mL.
pH: 5.0–7.5, in a 14% (w/w) solution of Maltitol Solution in carbon dioxide-free water
Water Determination: NMT 31.5%
Packaging and Storage: Preserve in well-closed containers. No storage requirements are specified.
Specifications of Maltitol BP Ph Eur Grade:
C12H24O11 --- 344.3 --- CAS 585-88-6
Action and use: Sweetening agent.
DEFINITION
4-O-α-d-Glucopyranosyl-d-glucitol (d-maltitol).
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Very soluble in water, practically insoluble in anhydrous ethanol.
IDENTIFICATION
First identification: A
Second identification: B, C, D
A. Infrared absorption spectrophotometry
Comparison maltitol CRS.
B. Melting point: 148C to 151C.
C. Specific optical rotation: + 105.5 to + 108.5 (anhydrous substance).
D. Thin-layer chromatography: To pass the test by chromatography.
Results The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a).
TESTS
Appearance of solution: The solution is clear and colourless.
Dissolve 5.0 g in water and dilute to 50 mL with the same solvent.
Conductivity: Maximum 20 microS/cm.
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.
Reducing sugars: Maximum 0.2 per cent, expressed as glucose equivalent.
Related substances:
To pass the test by Liquid chromatography.
Limits:
-any impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
-total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);
-disregard limit: the area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).
Lead: Maximum 0.5 ppm.
Nickel: Maximum 1 ppm.
Water: Maximum 1.0 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 less than 100 g/L of maltitol;
-less than 2.5 IU/g for parenteral preparations having a concentration of 100 g/L or more of maltitol.
IMPURITIES
A. D-glucitol (D-sorbitol),
B. O-α-d-glucopyranosyl-(1→4)-O-α-d-glucopyranosyl-(1→4)-d-glucitol (maltotriitol).
Specifications of Liquid Maltitol BP Ph Eur Grade:
Action and use: Excipient.
DEFINITION
Aqueous solution of a hydrogenated, partly hydrolysed starch, composed of a mixture of mainly 4-O-α-d-glucopyranosyl-d-glucitol (d-maltitol) with d-glucitol (d-sorbitol) and hydrogenated oligo- and polysaccharides.
Content:
-d-maltitol (C12H24O11): minimum 50.0 per cent m/m (anhydrous substance) and 95.0 per cent to 105.0 per cent of the content stated on the label;
-d-sorbitol (C6H14O6): maximum 8.0 per cent m/m (anhydrous substance);
-anhydrous substance: 68.0 per cent m/m to 85.0 per cent m/m.
CHARACTERS
Appearance: Clear, colourless, syrupy liquid.
Solubility: Miscible with water and with glycerol.
IDENTIFICATION
First identification: A
Second identification: B, C
A. Examine the chromatograms obtained in the assay.
Results The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (a).
B. Thin-layer chromatography: To pass the test.
Results The principal spot in the chromatogram obtained with the test solution is similar in position and colour to the principal spot in the chromatogram obtained with reference solution (a).
C. To 3 mL of a freshly prepared 100 g/L solution of pyrocatechol, add 6 mL of sulfuric acid while cooling in iced water. To 3 mL of the cooled mixture, add 0.3 mL of solution S (see Tests). Heat gently over a naked flame for about 30 s. A pink colour develops.
TESTS
Solution S: Dilute 7.0 g to 50 mL with water.
Appearance of solution: Solution S is clear and colourless.
Conductivity: Maximum 10 microS/cm, measured on undiluted liquid maltitol while gently stirring with a magnetic stirrer.
Reducing sugars: Maximum 0.2 per cent, calculated as glucose equivalent.
Lead: Maximum 0.5 ppm.
Nickel: Maximum 1 ppm.
Water: 15.0 per cent m/m to 32.0 per cent m/m, determined on 0.100 g. Use as solvent a mixture of equal volumes of anhydrous methanol and formamide. Carry out the titration at about 50C.
Specifications of Maltitol FCC Food Grade:
D-Maltitol; Hydrogenated Maltose; _-D-Glucopyranosyl-1,4-D-glucitol
C12H24O11 Formula weight 344.31
INS: 965 CAS: [585-88-6]
DESCRIPTION
Maltitol occurs as a white, crystalline powder containing small amounts of sorbitol and related polyhydric alcohols. It is very soluble in water and slightly soluble in ethanol.
Function: Sweetener; humectant; stabilizer.
REQUIREMENTS
Identification: To pass the test by thin-layer chromatography
Assay: Not less than 92.0% and not more than 100.5% of D-maltitol as C12H24O11, calculated on the dried basis.
Lead: Not more than 1 mg/kg.
Nickel: Not more than 1 mg/kg.
Other Hydrogenated Saccharides: Not more than 7.0%.
Reducing Sugars (as glucose): Not more than 0.3%.
Residue on Ignition: Not more than 0.1%.
Water: Not more than 1.5%.
Keywords: Maltitol Powder Liquid Solution IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 585-88-6 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
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
e-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated
8-oct-24
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.
Fast Selling IP BP Ph Eur EP USP NF JP Analytical Reagent FCC Food Grades of Chemicals by Anmol Chemicals
Ammonium Persulfate --- Acetic Acid Glacial --- Aluminum Chloride --- Ammonium bicarbonate --- Benzyl Alcohol --- Butylated Hydroxyanisole --- Butylated Hydroxytoluene --- Boric Acid --- Calcium Butyrate --- Calcium Chloride --- Calcium Hydroxide --- Calcium Lactobionate --- Calcium Saccharate --- Carbamide Peroxide --- Calcium Oxide --- Calcium Sulfate --- Chromic Chloride --- Fumaric Acid --- Magnesium Butyrate --- Magnesium Chloride --- Magnesium Sulfate --- Malic Acid --- Maleic Acid --- Manganese Chloride --- Manganese Sulfate --- Octyldodecanol --- Oleic acid --- Phenylethyl Alcohol --- Propylene Carbonate --- Potassium Hydroxide Pellets --- Potassium Alum --- Selenious Acid --- Sodium Acetate --- Sodium Bromate --- Sodium Selenite --- Sodium Perborate --- Sodium Hydroxide --- Sodium Sulphate --- Sodium Sulfide --- Sodium Thiosulfate --- Urea --- Zinc Chloride --- Zinc Sulphate ---
Maltitol
Powder Liquid Solution USP BP Ph Eur FCC Food Grades Manufacturers