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PHR1041

Supelco

Tetracycline hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Empirical Formula (Hill Notation):
C22H24N2O8 · HCl
CAS Number:
Molecular Weight:
480.90
Beilstein:
3844873
EC Number:
MDL number:
PubChem Substance ID:

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 480
traceable to Ph. Eur. T060000
traceable to USP 1651009

API family

tetracycline

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

220-223 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

Cl.CN(C)[C@H]1[C@@H]2C[C@H]3C(=C(O)[C@]2(O)C(=O)C(C(N)=O)=C1O)C(=O)c4c(O)cccc4[C@@]3(C)O

InChI

1S/C22H24N2O8.ClH/c1-21(31)8-5-4-6-11(25)12(8)16(26)13-9(21)7-10-15(24(2)3)17(27)14(20(23)30)19(29)22(10,32)18(13)28;/h4-6,9-10,15,25,27-28,31-32H,7H2,1-3H3,(H2,23,30);1H/t9-,10-,15-,21+,22-;/m0./s1

InChI key

XMEVHPAGJVLHIG-FMZCEJRJSA-N

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This Item
PHR1691PHR152031741
Tetracycline hydrochloride Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1041

Tetracycline hydrochloride

Tetracycline hydrochloride VETRANAL®, analytical standard

Supelco

31741

Tetracycline hydrochloride

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

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

format

neat

format

neat

format

neat

format

neat

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

-10 to -25°C

storage temp.

2-8°C

Quality Level

300

Quality Level

300

Quality Level

300

Quality Level

100

General description

Tetracycline hydrochloride is a broad-spectrum antibiotic, effective against both Gram-negative and Gram-positive microorganisms. Its aqueous solution has effective as a root canal irrigant for the removal of smear layer.
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.

Application

Tetracycline hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by kinetic spectrophotometric method.
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.

Biochem/physiol Actions

Mode of Action: Tetracycline passively diffuses through proin channels in the cell membrane, binding to 30S ribosomes and inhibits protein synthesis by preventing access of aminoacyl tRNA to the acceptor site on the mRNA-ribosome complex. It also binds to the bacterial 50S ribosomal subunit, altering the membrane and causing intracellular components to leak from bacterial cells. The inhibitory effects can be reversed by washing, suggesting that it is the reversibly bound antibiotic, and not the irreversibly bound drug, that is responsible for antibacterial action.

Mode of Resistance: The effects are inactivated via a loss of cell wall permeability.

Antimicrobial spectrum: Includes a wide range of antimicrobial activity against gram-positive and gram-negative bacteria.

Caution

This product should be frozen below 0°C and protected from light and moisture. In these conditions, the product has been shown to retain activity for 4 years. Stock solutions should be stored at -20°C and are stable at 37°C for 4 days.

Preparation Note

The product is freely soluble in water, soluble in methanol and ethanol but is insoluble in ether and hydrocarbons. In water, the product yields a clear, yellow-orange solution with heating and in 95% ethanol, 50 mg dissolved in 4 mL with heating yields a clear, yellow-green solution. Tetracycline is rapidly destroyed by alkali hydroxide solutions and standing water solutions become turbid due to hydrolysis and precipitation. The potency of tetracycline is reduced in solutions with pH below 2.

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 LRAA7192 in the slot below. This is an example certificate only and may not be the lot that you receive.

Signal Word

Warning

Hazard Classifications

Aquatic Acute 1 - Aquatic Chronic 2 - Eye Irrit. 2 - Repr. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Kinetic spectrophotometric method for the determination of tetracycline hydrochloride in pharmaceutical formulations
Ahmida NHS, et al.
Archives of Applied Science Research, 1(12) (2009)
Tetracycline HCl solution as a root canal irrigant
Haznedaro?lu F and Ersev H
Journal of Endodontics, 27(12), 738-740 (2001)
Measurement and correlation of solubility of tetracycline hydrochloride in six organic solvents
Zhao Y and Wang Y
The Journal of Chemical Thermodynamics, 57(12), 9-13 (2013)
T Bouchery et al.
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 19(2), 131-140 (2013-02-13)
Symbiotic associations between eukaryotes and microorganisms are frequently observed in nature, and range along the continuum between parasitism and mutualism. The genus Wolbachia contains well-known intracellular bacteria of arthropods that induce several reproductive phenotypes that benefit the transmission of the
Xu Huang et al.
Environmental science and pollution research international, 20(12), 9066-9074 (2013-07-03)
Six antibiotics, tetracyclines (TCs), and quinolones (QNs) in farmland soils from four coastal cities in Fujian Province of China were investigated. Oxytetracycline was most frequently detected, followed by enrofloxacin, ciprofloxacin, chlorotetracycline, ofloxacin, and tetracycline, with maximum concentrations of 613.2, 637.3

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