Magnesium Pidolate & BP Ph Eur EP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Magnesium Pidolate BP Ph Eur EP, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Magnesium Pidolate: CAS Number: 62003-27-4, EINECS EC Number: 263-365-7, Molecular Formula: C10H12N2O6Mg, Molecular Weight: 280.5 HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Magnesium Pidolate.

Magnesium pidolate, the magnesium salt of pidolic acid (pyroglutamic acid), is a mineral supplement.

Magnesium Pidolate BP Ph Eur Grade
Ph Eur
C10H12N2O6Mg -- 280.5 -- CAS 62003-27-4

DEFINITION
Magnesium bis[(2S)-5-oxopyrrolidine-2-carboxylate].
Content: 8.49 per cent to 8.84 per cent of Mg (Ar = 24.31) (anhydrous substance).

CHARACTERS
Appearance: Amorphous, white or almost white powder, hygroscopic.
Solubility: Very soluble in water, soluble in methanol, practically insoluble in methylene chloride.

IDENTIFICATION
A. Thin-layer chromatography.
Test solution: Dissolve 60 mg in 2 ml of water and dilute to 10 ml with methanol.
Reference solution: Dissolve 55 mg of pidolic acid CRS in 2 ml of water and dilute to 10 ml with methanol.
Plate:TLC silica gel plate.
Mobile phase: methanol, glacial acetic acid, methylene chloride (15:20:65 V/V/V).
Application:1 μl.
Development: Over 2/3 of the plate.
Drying: At 100-105C for 15 min.
Detection: Spray with concentrated sodium hypochlorite solution. Allow to stand for 10 min and spray abundantly with glacial acetic acid. Allow to stand again for 10 min and dry the plate at 100-105C for 2 min. Spray with potassium iodide and starch solution until spots appear.
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 the reference solution. The chromatogram obtained with the test solution may show 2 faint secondary spots.
B. To 0.15 ml of solution S (see Tests) add 1.8 ml of water. The solution gives the reaction of magnesium.

TESTS
Solution S: Dissolve 5.00 g in carbon dioxide-free water prepared from distilled water and dilute to 50.0 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
pH: 5.5 to 7.0 for solution S.
Specific optical rotation: - 23.3 to - 26.5 (anhydrous substance), determined on solution S.
Related substances:
Liquid chromatography.
Test solution: Dissolve 0.500 g of the substance to be examined in the mobile phase and dilute to 100.0 ml with the mobile phase.
Reference solution (a): Dilute 1.0 ml of the test solution to 100.0 ml with the mobile phase.
Reference solution (b): Dissolve 50.0 mg pidolate impurity B CRS in the mobile phase and dilute to 100.0 ml with the mobile phase. Dilute 5.0 ml of the solution to 50.0 ml with the mobile phase.
Reference solution (c): Dilute 10.0 ml of reference solution (b) to 100.0 ml with the mobile phase.
Reference solution (d): Dilute 1.0 ml of nitrate standard solution (100 ppm NO3) to 100.0 ml with the mobile phase.
Reference solution (e): Dilute 6.0 ml of reference solution (a) to 10.0 ml with reference solution (b).
Column:
size: = 0.25 m, Ø = 4.6 mm;
stationary phase: octadecylsilyl silica gel for chromatography (5 μm).
Mobile phase: Dissolve 1.56 g of sodium dihydrogen phosphate R in 1000 ml of water R and adjust to pH 2.5 with a 10 per cent V/V solution of phosphoric acid R.
Flow rate: 1.5 ml/min.
Detection: Spectrophotometer at 210 nm.
Injection: 10 μl loop injector; inject the test solution and reference solutions (b), (c), (d) and (e).
Run time: 4 times the retention time of pidolic acid.
Retention times: Pidolic acid = about 4.5 min; impurity B = about 7.5 min.
System suitability: Reference solution (e):resolution: minimum 10 between the peaks due to pidolic acid and to impurity B.
Limits:
impurity B: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
total of other impurities: not more than half of the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);
disregard limit: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent); disregard any peak corresponding to the nitrate ion (NO3–).

Impurity A
Thin-layer chromatography.
Test solution: Dissolve 0.250 g of the substance to be examined in 4 ml of water and dilute to 50.0 ml with methanol.
Reference solution (a): Dissolve 60.0 mg of glutamic acid R in 50 ml of water R and dilute to 100.0 ml with methanol. Dilute 1.0 ml of the solution to 20.0 ml with methanol.
Reference solution (b): Dissolve 10 mg of glutamic acid and 10 mg of aspartic acid in water and dilute to 25 ml with the same solvent. Dilute 1 ml of the solution to 10 ml with water.
Plate:TLC silica gel plate R.
Mobile phase: glacial acetic acid, water, butanol (20:20:60 V/V/V).
Application: 5 μl.
Development: Over 2/3 of the plate.
Drying: In air.
Detection: Spray with ninhydrin solution and heat at 100-105C for 15 min.
System suitability: The test is not valid unless the chromatogram obtained with reference solution (b) shows 2 clearly separated spots.
Limit:
impurity A: any spot corresponding to impurity A in the chromatogram obtained with the test solution is not more intense that the spot in the chromatogram obtained with reference solution (a) (0.6 per cent).
Chlorides: Maximum 500 ppm.
Nitrates: Examine the chromatogram obtained with the test solution in the test for related substances.
Limit:
nitrates: not more than the area of the principal peak in the chromatogram obtained with reference solution (d) (200 ppm).
Sulphates: Maximum 0.1 per cent.
Arsenic: Maximum 2 ppm.
Iron: Maximum 200 ppm.
Heavy metals: Maximum 20 ppm.
Water: Maximum 8.0 per cent, determined on 0.200 g.

ASSAY
Dissolve 0.300 g in 50 ml of water. Carry out the complexometric titration of magnesium.
1 ml of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg.

IMPURITIES
A. glutamic acid,
B. (2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentanedioic acid.

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Magnesium Pidolate SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 27-Oct-20

Product Name & Other Names: Magnesium Pidolate or Magnesium salt of pidolic acid.
Synonym: Magnesium salt of pidolic acid, Pyroglutamic acid, Magnesium (S)-2-pyrrolidone-5-carboxylate, Magnesium 5-oxo-L-proline.
CAS Number: 62003-27-4
EINECS EC Code: 263-365-7
Molecular Formula: C10H12N2O6Mg
Molecular Weight: 280.5
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.

Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.

Flammability of the Product: Non-flammable.
Products of Combustion: Carbon oxides, nitrogen oxides (NOx), Magnesium oxide.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Wear self-contained breathing apparatus for firefighting if necessary.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Ventilate area of leak or spill. Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment Cleanup procedures and Storage:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents and acids. Hygroscopic.

Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume, or mist, use ventilation to keep exposure to airborne contaminants low.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice.

Physical state and appearance: Solid white crystals or powder.
Odor: Not available.
Odor threshold: Not available.
pH (10% soln/water): about 5.5 to 7.
Relative density: Not available.
Melting Point: Not available..
Boiling Point: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Soluble in water.
Viscosity: Not available.
Molecular Formula: C10H12N2O6Mg
Molecular Weight: 280.5

Stability: It is stable in closed containers under recommended storage & handling.
Conditions of instability: Incompatible materials, Moisture
Incompatibility with various substances: Avoid high temperatures, sparks, open flames, and moisture. Avoid contact with strong oxidizing agents.
Polymerization: Will not occur.

Toxicological Data: Not available.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to Fish: No information available.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.

DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods
IMDG/IMO: Not dangerous goods
IATA: Not dangerous goods.

USA Regulations:
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards: No SARA Hazards
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.

DISCLAIMER: The information and recommendations set forth herein are presented in good faith and believed correct as of the date hereof. It is compiled from various sources and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

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