(±)-1,2-Propanediol ≥99.5% USP, Multi-Compendial, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Synonyms:
Propylene glycol
, (±)-1,2-Propylene glycol
, 1,2-Dihydroxypropane
, 1,2-Propanediol
, (±)-1,2-Dihydroxy propane
Management of Change (MOC) category = R
BAKR9404-03
BAKR9404-03
JT9404-03CS
2383.11
USD
JT9404-03
CAJT9404-03
(±)-1,2-Propanediol ≥99.5% USP, Multi-Compendial, J.T.Baker®
Propylene glycol
Formula:
CH₃CH(OH)CH₂OH MW: 76.1 g/mol Melting Pt: –59 °C Flash Pt: 99 °C Storage Temperature: Ambient |
MDL Number:
MFCD00064272 CAS Number: 57-55-6 EINECS: 200-338-0 Merck Index: 13,07947 |
Specification Test Results
Meets U.S.P Requirements | |
GMP Manufactured Product | |
Meets J.P. Chemical Specifications | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Specific Gravity at 25°/25°C | 1.035 - 1.037 |
USP - Acidity | Passes Test |
USP - Water (H₂O)(by Karl Fischer titrn) | ≤ 0.2 % |
USP - Identification A (IR) | Passes Test |
USP - Identification B - Diethylene glycol | ≤ 0.05 % |
USP - Identification B - Ethylene glycol | ≤ 0.05 % |
USP - Identification C | Passes Test |
USP - Residue on Ignition | ≤ 0.007 % |
USP - Chloride (Cl) | ≤ 0.007 % |
USP - Sulfate (SO₄) | ≤ 0.006 % |
USP - Assay (CH₃CHOHCH₂OH) | ≥ 99.5 % |
Endotoxin Concentration (EU/g) | ≤ 2.5 |
EP/BP - Relative Density (d²º₂₀) | 1.035 - 1.040 |
EP/BP - Refractive Index at 20°C | 1.431 - 1.433 |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Identification D | Passes Test |
EP/BP - Appearance | Passes Test |
EP/BP - Acidity | Passes Test |
EP/BP - Oxidizing Substances | Passes Test |
EP/BP - Reducing Substances | Passes Test |
EP/BP - Water (H₂O) | ≤ 0.2 % |
EP/BP - Ash (sulfated) | ≤ 0.01 % |
JP - Identification A | Passes Test |
JP - Identification B | Passes Test |
JP - Specific Gravity at 20°/20°C | 1.035 - 1.040 |
JP - Acidity | Passes Test |
JP - Chloride (Cl) | ≤ 0.007 % |
JP - Sulfate (SO₄) | ≤ 0.002 % |
JP - Heavy Metals (as Pb) | ≤ 5 ppm |
JP - Arsenic (As) | ≤ 2 ppm |
JP - Glycerin | Passes Test |
JP - Water (H₂O) | ≤ 0.5 % |
JP - Residue on Ignition | ≤ 0.005 % |
JP - Distilling Range (Lower) | 184 - 189 °C |
JP - Distilling Range (Upper) | 184 - 189 °C |
JP - Ethylene Glycol | ≤ 0.1 % |
JP - Diethylene Glycol | ≤ 0.1 % |
JP - Any Other Impurity | ≤ 0.1 % |
JP - Total Impurities | ≤ 1.0 % |
Microbial Testing – Total Aerobic Microbial Count (USP) | ≤ 10 cfu/mL |
Microbial Testing – Total Yeast and Mold Count (USP) | ≤ 10 cfu/mL |
Microbial Testing - Salmonella (USP) | Negative |
Microbial Testing - Escherichia coli (USP) | Negative |
Microbial Testing - Staphylococcus aureus (USP) | Negative |
Microbial Testing - Pseudomonas aeruginosa (USP) | Negative |
Microbial Testing -Bile tolerant gram-negative bacteria | Negative |
Microbial Testing – Clostridia | Negative |
Microbial Testing - Candida albicans | Negative |
Trace Impurities - Cadmium (Cd) | ≤ 200 ppb |
Trace Impurities - Lead (Pb) | ≤ 500 ppb |
Trace Impurities - Arsenic (As) | ≤ 1500 ppb |
Trace Impurities - Mercury (Hg) | ≤ 300 ppb |
Trace Impurities - Cobalt (Co) | ≤ 500 ppb |
Trace Impurities - Vanadium (V) | ≤ 1000 ppb |
Trace Impurities - Nickel (Ni) | ≤ 2000 ppb |
Trace Impurities - Thallium (Tl) | ≤ 800 ppb |
Trace Impurities - Gold (Au) | ≤ 10000 ppb |
Trace Impurities - Palladium (Pd) | ≤ 1000 ppb |
Trace Impurities - Iridium (Ir) | ≤ 1000 ppb |
Trace Impurities - Osmium (Os) | ≤ 1000 ppb |
Trace Impurities - Rhodium (Rh) | ≤ 1000 ppb |
Trace Impurities - Ruthenium (Ru) | ≤ 1000 ppb |
Trace Impurities - Selenium (Se) | ≤ 8000 ppb |
Trace Impurities - Silver (Ag) | ≤ 1000 ppb |
Trace Impurities - Platinum (Pt) | ≤ 1000 ppb |
Trace Impurities - Lithium (Li) | ≤ 25000 ppb |
Trace Impurities - Antimony (Sb) | ≤ 9000 ppb |
Trace Impurities - Barium (Ba) | ≤ 70000 ppb |
Trace Impurities - Molybdenum (Mo) | ≤ 150000 ppb |
Trace Impurities - Copper (Cu) | ≤ 30000 ppb |
Trace Impurities - Tin (Sn) | ≤ 60000 ppb |
Trace Impurities - Chromium (Cr) | ≤ 110000 ppb |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. |
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