PHR1145

Doxycycline hyclate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Doxycycline hydrochloride hemiethanolate hemihydrate
• Empirical Formula (Hill Notation): C₂₂H₂₄N₂O₈ · HCl · 0.5H₂O · 0.5C₂H₆O
• CAS Number: 24390-14-5
• Molecular Weight: 512.94
• Beilstein: 5702728
• MDL number: MFCD07357237
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823165
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 780; traceable to Ph. Eur. D3000000; traceable to USP 1226003
• API family: doxycycline
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C
• SMILES string: Cl[H].Cl[H].[H]O[H].CCO.C[C@@H]1C2[C@H](O)C3[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C2C(=O)c4c(O)cccc14.C[C@@H]5C6[C@H](O)C7[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]7(O)C(O)=C6C(=O)c8c(O)cccc58
• InChI: 1S/2C22H24N2O8.C2H6O.2ClH.H2O/c2*1-7-8-5-4-6-9(25)11(8)16(26)12-10(7)17(27)14-15(24(2)3)18(28)13(21(23)31)20(30)22(14,32)19(12)29;1-2-3;;;/h2*4-7,10,14-15,17,25,27-29,32H,1-3H3,(H2,23,31);3H,2H2,1H3;2*1H;1H2/t2*7-,10?,14?,15-,17-,22-;;;;/m00..../s1
• InChI key: HALQELOKLVRWRI-ZVACAFRPSA-N

Description

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.
Doxycycline, the semi-synthetic analog of tetracycline, is a broad-spectrum antibiotic employed in medicine and veterinary applications, is known for its action against a huge range of gram positive and gram negative bacteria. It is prescribed against infections spread by rickettsiae, mycoplasmas and chlamydiae.[1][2]

Application

Doxycycline hyclate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and biological samples[2] by various chromatography[1][3][2] and spectrophotometric[4] techniques.

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: Doxycycline hyclate inhibits the inflammatory response to the Lyme Disease Spirochete Borrelia burgdorferi.

Activity Spectrum: Effective against a broad spectrum inhibitor of matrix metalloproteinases in vivo.

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 LRAC0269 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.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Warning
• Hazard Statements: H302,H315,H319,H335,H361fd,H412
• Precautionary Statements: P202 - P273 - P301 + P312 - P302 + P352 - P305 + P351 + P338 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Chronic 3 - Eye Irrit. 2 - Repr. 2 - Skin Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable