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Merck

PHR1051

Propylene glycol

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

1,2-Propanediol, Propylene glycol

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1.5 G

$198.00

$198.00


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About This Item

Linear Formula:
CH3CH(OH)CH2OH
CAS Number:
Molecular Weight:
76.09
NACRES:
NA.24
E Number:
E1520
PubChem Substance ID:
UNSPSC Code:
41116107
EC Number:
200-338-0
MDL number:
Beilstein/REAXYS Number:
1340498

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Product Name

Propylene glycol, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

DNIAPMSPPWPWGF-UHFFFAOYSA-N

InChI

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

SMILES string

CC(O)CO

grade

certified reference material
pharmaceutical secondary standard

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

Quality Level

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This Item
Y00015471576708BP868
technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

application(s)

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

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical
pharmaceutical small molecule

format

neat

format

neat

format

neat

format

neat

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

-

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

storage temp.

2-30°C

storage temp.

2-8°C

storage temp.

-

storage temp.

2-8°C

Analysis Note

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

Application

Propylene glycol may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.[1][2][3]
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.

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.[3]

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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.
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

10 - Combustible liquids

wgk

WGK 1

flash_point_f

219.2 °F - closed cup

flash_point_c

104 °C - closed cup


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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Analysis of aldehydes in excipients used in liquid/semi-solid formulations by gas chromatography-negative chemical ionization mass spectrometry
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)
C Fernandez et al.
Journal of pharmaceutical and biomedical analysis, 24(1), 155-165 (2000-12-07)
The aim of this study was to determine the skin penetration of benzophenone-3 in vitro and in vivo in order to investigate a possible influence of formulation. Six different vehicles, three solvents and three different emulsion types were evaluated in
R S Rajasenan et al.
Toxicology and applied pharmacology, 135(1), 89-99 (1995-11-01)
Engrafting components of human immune systems in severe combined immunodeficient (SCID) mice has been utilized to investigate the pathogenesis of several human autoimmune diseases and may provide a model for studying idiosyncratic drug toxicity. The purpose of this investigation was
H K Vaddi et al.
Journal of pharmaceutical sciences, 91(7), 1639-1651 (2002-07-13)
The respective alcoholic terpenes carvacrol, linalool, and alpha-terpineol were used at 5% w/v in propylene glycol (PG) to increase the in vitro permeation of haloperidol (HP) through human skin. The possible enhancement mechanism was then elucidated with HP-stratum corneum (SC)

Questions

1–2 of 2 Questions  
  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

      Helpful?

  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

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