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PHR1140

Supelco

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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About This Item

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

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

SMILES string

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

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

InChI key

BWHLPLXXIDYSNW-UHFFFAOYSA-N

Gene Information

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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.

Application

Ketorolac Tromethamine may be used pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography and spectrophotometric technique.
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.
Values of analytes vary lot to lot.

Footnote

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.

Recommended products

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.

Pictograms

Skull and crossbones

Signal Word

Danger

Hazard Statements

Hazard Classifications

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

Target Organs

Respiratory system

Storage Class Code

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


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.

JAN Code

PHR1140-500MG-PW:
PHR1140-500MG:


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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)
Michel Weber et al.
Acta ophthalmologica, 91(1), e15-e21 (2012-09-14)
To determine whether indomethacin 0.1% eye drops are at least as effective as ketorolac 0.5% eye drops in treating ocular inflammation following cataract surgery. Prospective, multicenter, investigator-masked, parallel-group, randomized, active-controlled clinical trial. Cataract patients were randomized in a 1:1 ratio
Stephen J Kim et al.
Archives of ophthalmology (Chicago, Ill. : 1960), 130(4), 456-460 (2012-04-12)
To investigate the adverse ocular effects of intravitreal ketorolac (4 mg) in patients with chronic uveitis and complications of chronic inflammation (macular edema). We conducted a prospective phase 1 clinical trial involving 10 eyes of 10 adult patients with chronic
V Pfaffenrath et al.
Cephalalgia : an international journal of headache, 32(10), 766-777 (2012-06-20)
Ketorolac is a non-triptan, non-opioid, mixed cyclooxygenase (COX)1/2-inhibitor for short-term management of moderate-to-severe acute pain. This trial evaluated an intranasal formulation of ketorolac tromethamine (SPRIX®) containing 6% lidocaine (ROX-828) for the acute treatment of migraine with and without aura as

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