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PHR1140

Ketorolac Tromethamine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Ketorolac tris salt, (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid tris salt, Toradol

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500 MG

$166.00

$166.00


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About This Item

Empirical Formula (Hill Notation):
C15H13NO3 · C4H11NO3
CAS Number:
Molecular Weight:
376.40
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:

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Product Name

Ketorolac Tromethamine, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C15H13NO3.C4H11NO3/c17-14(10-4-2-1-3-5-10)13-7-6-12-11(15(18)19)8-9-16(12)13;5-4(1-6,2-7)3-8/h1-7,11H,8-9H2,(H,18,19);6-8H,1-3,5H2

SMILES string

NC(CO)(CO)CO.OC(=O)C1CCn2c1ccc2C(=O)c3ccccc3

InChI key

BWHLPLXXIDYSNW-UHFFFAOYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000486
traceable to USP 1356665

API family

ketorolac

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

Gene Information

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This Item
1356665Y0000626Y0000486
technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

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.

2-8°C

storage temp.

2-8°C

agency

traceable to Ph. Eur. Y0000486

agency

-

agency

-

agency

-

Analysis Note

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

Application

Ketorolac Tromethamine may be used pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[1][2] using reversed-phase high-performance liquid chromatography[1] and spectrophotometric technique.[2]
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. Ketorolac Tromethamine belongs to the class of non-steroidal anti-inflammatory drugs, and its mode of action involves the inhibition of the bodily synthesis of prostagladins. It exhibits anti-inflammatory, antipyretic and analgesic effects.[1]

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 LRAA7191 in the slot below. This is an example certificate only and may not be the lot that you receive.
Values of analytes vary lot to lot.

pictograms

Skull and crossbones

signalword

Danger

Hazard Classifications

Acute Tox. 3 Oral - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

target_organs

Respiratory system

Storage Class

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 3

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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A validated RP-HPLC method for simultaneous estimation of febuxostat and ketorolac tromethamine in pharmaceutical formulations
Gandla K, et al.
Journal of Drug Delivery and Therapeutics, 2(3) (2012)
Simultanious spectrophotometric estimation of ofloxacin and ketorolac tromethamine in ophthalmic dosage form
Fegade DJ, et al.
International Journal of ChemTech Research, 1(3), 189-194 (2009)
V R Sinha et al.
Expert opinion on drug delivery, 6(9), 961-975 (2009-08-12)
Ketorolac tromethamine (KT) is a non-steroidal anti-inflammatory drug that belongs to the class of heteroaryl acetic acid derivatives. It is a non-selective cyclooxygenase (COX) inhibitor, being marketed in the racemate form. Most of its analgesic and COX inhibitory activity is
Gwen M Grimsby et al.
Mayo Clinic proceedings, 87(11), 1089-1097 (2012-10-13)
To evaluate the efficacy and safety of a novel, continuous intravenous infusion of ketorolac, a powerful nonopioid analgesic, for postoperative pain control. A prospective, double-blind, randomized, placebo-controlled trial of a continuous infusion of ketorolac tromethamine in 1 L of normal
Aida Kulo et al.
European journal of drug metabolism and pharmacokinetics, 38(1), 1-4 (2012-11-28)
Compared to female volunteers or postpartum, ketorolac clearance is higher at delivery. To explore the alterations that explain this higher clearance, urinary ketorolac metabolites collected at delivery (n = 40) were compared to female volunteers (unpaired, n = 8) or postpartum (paired, n = 8) following

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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