Active Pharmaceutical Ingredients Ascorbic Acid Vitamin C Food Grade

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Wuhan Uni-Pharma Bio-Tech Co., Ltd.

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Hormones and Regulation of Endocrine Function of Drug, Vitamins and Minerals Deficiency Drug
GMP
Food Grade
Analysis reagent
Solid
Not Volatile
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China
2936270010
Product Description
Certificate of Analysis
 
Product Name Ascorbic AcidInspection Date2016.06.11
Manufacturing Date2016.06.06Expire Date2019.05.29
Lot NO160606-C01CAS NO36431-82-0Lot Size27000KG
      
 
 
 
TEST ITEMSPECIFICATIONSTEST RESULTS
CharactersWhite or almost white,crystalline powder or colourless crystalsWhite crystalline powder
IdentificationCorrespondsCorresponds
Melting range189ºC~193ºC191ºC
pH(5%W/V)2.1~2.62.32
pH(2%W/V)2.4~2.82.54
Specific rotation+20.5°~ +21.5°+21.0°
Apperance of solutionSolutions is clear and not more intensely cloured than reference colution BY7 Up to standard
Heavy metals10ppm<10ppm
Assay99.0%~100.5%99.6%
Copper5ppm0.21ppm
Iron2ppm0.12ppm
Mercury1ppm0.05ppm
Arsenic3ppm<3ppm
Lead2ppm0.06 ppm
Oxalic acid(impurity E:)0.2%<0.2%
Loss on drying0.4%0.03%
Sulphated ash0.1%0.03%
Related substances:Impurty C: 0.15%<0.01%
Impurty D: 0.15%<0.01%
Unspecified impurities: 0.10%ND
Total:≤0.2%ND
Residual solvents:Methanol: 3000ppm49ppm
Microbiological examinationTAMC:103 cfu/gCorresponds
TYMC:102cfu/gCorresponds
E.coli:AbsenceCorresponds
ConclusionThe product conforms to the standard of BP2014/EP8/USP38/E300/FCC7
 
 
 
 
 
SECTION 2.     COMPOSITION/INFORMATION ON INGREDIENTS
 
MSDS Name:                  Ascorbic acid
Synonym:                        Vitamin C, L-Ascorbic acid
Chemical Name:             (5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxfuran-2 (5H)-one
CAS No.:                         50-81-7
Content:                          100% (Ascorbic acid)
Hazard Symbols:            None Listed.
Risk Phrases:                  None Listed.
 
 
SECTION 3.     HAZARDS IDENTIFICATION
 
Invasive Pathway:          Inhalation, ingestion and skin
Health Hazards:              No information found. Environment Hazards: No information found. Explosive Hazards:       Flammable.
 
 
SECTION 4.     FIRST AID MEASURES
 
Eyes:                                Immediately lift  the upper  and  lower  eyelids eyelid up,  flush eyes with plenty of running water. Get medical aid.
Skin:                                Flush  skin  with  plenty  of  water  while  removing   contaminated clothing and shoes. Get medical aid if irritation develops or persists.
Ingestion:                        If large amounts are swallowed, get medical aid immediately.
Inhalation:                      Get medical aid immediately. Remove from exposure and move   to fresh air immediately. If breathing is difficult, give oxygen.
 
 
SECTION 5.     FIRE FIGHTNG MEASURES
 
General Information: Flammable. Fire is possible at elevated temperatures or by  contact with an ignition source.
Extinguisher:                  Dry powder, foam and water spray.
Extinguishing Note: Don't stay in a danger  area  unless  the  chemical  safeguard and oxygen supply equipment are prepared, avoiding the chemicals into the surface water and ground water.

 
 
SECTION 6.     ACCIDENTAL RELEASE MEASURES
 
Personal Protection:    Don't inhale the steam. Use proper personal protective  equipment as indicated in SECTION 8.
Environmental  Protection:  The  chemicals  are  not  allowed  to  charge  into  the  drainage
system without disposal.
Cleaning:                       Collect  and  reclaim  the  leaking-materials  with  secure  method  or transport to a disposal site to further dispose. Then clean the contaminated area.
 
 
SECTION 7.     HANDLING AND STORAGE
 
Handling:                        Avoid  contact  with eyes,  skin,  and  clothing.  Avoid  ingestion and inhalation. Use adequate ventilation.
Storage:                           Keep  intightly closed  container,  store  incool,  dry, ventilated place. Store protected from light and incompatible substances. Containers of this material may be hazardous when  empty since they retain product residues (dust, solids); observe all warnings and precautions listed for the product.
 
 
SECTION 8.     EXPOSURE CONTROLS/PERSONAL PROTECTION
 
Engineering Controls: Use adequate ventilation to keep airborne concentrations low. Immediately change the contaminated clothing. Daub the skin with cream. Wash the face and hands after work. Don't inhale its steam.
Exposure Limits:            No information found.

Personal Protective Equipment:

Eyes:                          Wear appropriate protective eyeglasses or chemical safety goggles. Skin:     Wear appropriate protective gloves to prevent skin exposure.
Clothing:                    Wear appropriate protective clothing to prevent skin exposure.
Respirators:                Wear  appropriate   protective  dustproof  respirator   to   prevent inhalation.
Others:                       No  smoking at the work site. Pay attention to  personal   sanitation.
Avoid contacting repeatedly and constantly.
 
 
SECTION 9.     PHYSICAL AND CHEMICALS PROPERTIES
 
Physical State:                       Solid
Color:                                     White or almost white
Odor:                                      Odorless
pH:                                          2.2~2.5 (50 g/L H2O, 20ºC)
Melting Point:                        190~192ºC (with decomposition)
Boiling Point:                         Not available
Flash Point:                            Not available

Ignition Temperature:          380ºC

Explosion Limits (lower):      Not available.
Explosion Limits (upper):     Not available.
Solubility:                             Freely soluble in water (330g/L, 24ºC), soluble in ethanol (96%)
(20g/L, 20ºC)
Density:                                  1.65 g/cm3
Appearent Density:               500~900 kg/m3
Molecular Formula:              C6H8O6
Molecular Weight:                176.1
Specific Optical Rotation:     +20.5° ~ +21.5°
Other Properties:                   Becoming discolored on exposure to air and moisture.
 
 
SECTION 10.   STABILITY AND REACTIVITY
Chemical Stability:                                     Stable  under  ordinary  conditions  of  use  and storage. Aqueous solutions are  rapidly oxidized by air.
Conditions to Avoid:                                  Heat and light.
Incompatibilities with Other Materials:  Metals, especially the copper, iron, aluminum and
zinc. Oxidant, becoming discolored on exposured to air and moisture.
Hazardous Decomposition Products:       May  produce  acrid  smoke  and  irritating  fumes
when heated to decomposition.
Hazardous Polymerization:                       Will not occur.
 
 
SECTION 11.   TOXICOLOGICAL INFORMATION
 
Emergency Toxicity:                                  Oral: LD50: 11900 mg/kg (Rat). Investigated as a tumorigen, mutagen, and reproductive effector.
Skin Irritative Test                                     No irritating (Rabbit).
Eye Irritative Test                                      Slightly irritating (Rabbit).
Other:                                                          Be careful when dispose the product.
 
 
SECTION 12.   ECOLOGICAL INFORMATION
 
Ecological Toxicity:                                    Fish: Onchorhynchus mykiss LC50: 1020mg/L/96 h acid; L.idus LC50: 33000 mg/L/48 h.
Biological Degradation:                             Degradation, will not affect the disposal of   waste
water if in a suitable disposal.
Biological Enrichment or Accumulation: Not occur.
 
 
SECTION 13.   DISPOSAL CONSIDERATIONS
 
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing, use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal,

state and local requirements.
 
 
SECTION 14.   TRANSPORT INFORMATION
 
Not regulated.
 
 
SECTION 15.   REGULATORY INFORMATION
 
Not available.
 
 
SECTON 16.    OTHER INFORMATION
 
Label Hazard Warning: As part of good industrial and personal hygiene and safety procedure, avoid all unnecessary exposure to the  chemical substance and ensure prompt removal from skin, eyes and clothing.
Label First Aid:              Not applicable.
Product Use:                   Laboratory Reagent.
 
The above information is believed to be correct but does not support to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. The conditions or methods of handling, storage, use or disposal of the product are beyond our control and may be beyond our knowledge. It does not represent any guarantee of the properties of the product. Yibin Ereal Chemical shall not be held liable for any damage resulting from handling or from contact with the above product.
 


 
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