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PHR1051

Supelco

Propylene glycol

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
1,2-Propanediol, Propylene glycol
Linear Formula:
CH3CH(OH)CH2OH
CAS Number:
Molecular Weight:
76.09
Beilstein:
1340498
EC Number:
MDL number:
PubChem Substance ID:
E Number:
E1520
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1576708

vapor density

2.62 (vs air)

vapor pressure

0.08 mmHg ( 20 °C)

API family

propylene glycol

CofA

current certificate can be downloaded

autoignition temp.

779 °F

expl. lim.

12.5 %

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

refractive index

n20/D 1.432 (lit.)

bp

187 °C (lit.)

mp

−60 °C (lit.)

density

1.036 g/mL at 25 °C (lit.)

application(s)

cleaning products
cosmetics
flavors and fragrances
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CC(O)CO

InChI

1S/C3H8O2/c1-3(5)2-4/h3-5H,2H2,1H3

InChI key

DNIAPMSPPWPWGF-UHFFFAOYSA-N

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Propylene glycol Pharmaceutical Secondary Standard; Certified Reference Material

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PHR1051

Propylene glycol

Propylene glycol ≥99.5% (GC), FCC, FG

Sigma-Aldrich

W294004

Propylene glycol

Propyl gallate Pharmaceutical Secondary Standard; Certified Reference Material

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Propylparaben Pharmaceutical Secondary Standard; Certified Reference Material

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PHR1010

Propylparaben

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

cleaning products
cosmetics
flavors and fragrances
food and beverages
personal care
pharmaceutical (small molecule)

application(s)

flavors and fragrances

application(s)

cleaning products
cosmetics
flavors and fragrances
food and beverages
personal care
pharmaceutical (small molecule)

application(s)

cleaning products
cosmetics
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

format

-

format

neat

format

neat

storage temp.

2-30°C

storage temp.

-

storage temp.

2-30°C

storage temp.

2-30°C

Quality Level

300

Quality Level

400

Quality Level

300

Quality Level

300

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Propylene glycol is commonly utilized as a penetration enhancer in topical dermatological formulations, either alone or in combined form with other penetration enhancing agents, like fatty acids.

Application

Propylene glycol may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB9658 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

10 - Combustible liquids

WGK

WGK 3

Flash Point(F)

217.4 °F - closed cup

Flash Point(C)

103 °C - closed cup


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

FSL

Flammable liquids
Type 3 petroleums
Hazardous rank III
Water soluble liquid

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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25G
Pack Size/Quantity

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705578-5MG-PW

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MMYOMAG-74K-13

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Li Z, et al.
Journal of Chromatography A, 1160(1-2), 299-305 (2007)
Effect of finite doses of propylene glycol on enhancement of in vitro percutaneous permeation of loperamide hydrochloride
Trottet L, et al.
International Journal of Pharmaceutics, 274(1-2), 213-219 (2004)
Gai Ling Li et al.
Journal of controlled release : official journal of the Controlled Release Society, 84(1-2), 49-57 (2002-10-26)
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R S Rajasenan et al.
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Plasma acetone turnover rates were measured with the primed continuous infusion of 2-[14C]acetone in patients with moderate to severe diabetic ketoacidosis. Plasma acetone turnover rates ranged from 1.52 to 15.9 mumol X kg-1 X min-1 (108-1038 mumol X 1.73 m-2

Protocols

GC Analysis of Glycols on Nukol™

99%; Glycerol, ≥99.5%; Tetraethylene glycol, 99%

Chromatograms

suitable for GC

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