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Merck

PHR1027

Guaifenesin

certified reference material, pharmaceutical secondary standard

Synonym(s):

Guaiacol glyceryl ether, 3-(o-Methoxyphenoxy)-1,2-propanediol, Glycerol guaiacolate, Guaifenesin

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About This Item

Empirical Formula (Hill Notation):
C10H14O4
CAS Number:
Molecular Weight:
198.22
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
EC Number:
202-222-5
MDL number:

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Product Name

Guaifenesin, certified reference material, pharmaceutical secondary standard

InChI key

HSRJKNPTNIJEKV-UHFFFAOYSA-N

InChI

1S/C10H14O4/c1-13-9-4-2-3-5-10(9)14-7-8(12)6-11/h2-5,8,11-12H,6-7H2,1H3

SMILES string

COc1ccccc1OCC(O)CO

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. G0700000
traceable to USP 1301007

API family

guaifenesin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

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1 of 4

This Item
G0700000Y00019561301007
application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

-

application(s)

pharmaceutical (small molecule)

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

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.

2-8°C

storage temp.

-

agency

traceable to Ph. Eur. G0700000

agency

-

agency

-

agency

-

Analysis Note

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

Application

Guaifenesin may be used as a reference standard in determining the concentration of guaifenesin present in pharmaceutical formulations and human plasma using colorimetric technique[1] and high performance liquid chromatography (HPLC), respectively.[2] It may also be used pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography technique.[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

Guaifenesin is an expectorant, widely used in the treatment of cough. Its mode of action involves the alleviating of cough discomfort by increasing sputum volume and decreasing its viscosity, thus resulting in effective cough.[4]
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.

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.
To see an example of a Certificate of Analysis for this material enter LRAC3180 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark

signalword

Warning

hcodes

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

13 - Non Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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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Sensitive spectrophotometric method for quantitation of guaifenesin and dropropizine in their dosage forms
Abdallah.MO, et al.
International Journal of Analytical Chemistry (2010)
Development and validation of a high-performance liquid chromatographic method for the determination of methocarbamol in human plasma
Naidong W, et al.
Journal of Chromatography. B, Biomedical Applications, 287-292 (1994)
Development and validation of stability indicating the RP-HPLC method for the estimation of related compounds of guaifenesin in pharmaceutical dosage forms
Reddy PS, et al.
Pharmaceutical Methods, 2(4), 229-234 (2011)
Monzure-Khoda Kazi et al.
Journal of chromatography. A, 1231, 22-30 (2012-03-01)
This work addresses optimization of an improved single-column chromatographic (ISCC) process for the separation of guaifenesin enantiomers. Conventional feed injection and fraction collection systems have been replaced with customized components facilitating simultaneous separation and online monitoring with the ultimate objective
Mallinath B Hadimani et al.
Journal of medicinal chemistry, 56(12), 5071-5078 (2013-06-14)
In diabetic patients, an early index of peripheral neuropathy is the slowing of conduction velocity in large myelinated neurons and a lack of understanding of the basic pathogenic mechanisms hindered therapeutics development. Racemic (R/S)-guaifenesin (1) was identified as a potent

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

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  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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