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English to Russian: Certificate of Analysis General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Light pink coloured round biconvex shaped film-coated tablet plain on both sides.
The retention times of the principal peaks in
the chromatogram obtained with the sample solution are
similar to those due to XXX and to YYY
in the chromatogram obtained with the standard solution
during assay.
Translation - Russian Круглая двояковыпуклая таблетка, покрытая оболочкой светло-розового цвета, гладкая с обеих сторон.
Время удерживания основных пиков на хроматограмме испытуемого раствора соответствует времени удерживания пиков XXX и YYY на хроматограмме стандартного раствора в испытании «Количественное определение».
English to Russian: Uniformity of dosage units General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Uniformity of Dosage Unit By W.V.
Acceptance value should be less than or equal to Li% (Li
is 15.0)
Translation - Russian Однородность дозированных единиц, объемно-массовый метод
Показатель приемлемости должен быть меньше или равен L1 % (L1 составляет 15 %)
English to Russian: UV Identification
Source text - English Identification of XXX YYY Fumarate by UV
UV spectra of the sample should correspond to that of standard.
Translation - Russian Идентификация XXX YYY фумарата методом УФ-спектроскопии
УФ спектры образца должны соответствовать таковым для стандарта.
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Experience
Years of experience: 18. Registered at ProZ.com: Mar 2018.
- Professional chemist (Ph.D.) with 10+ years of
hands-on experience leading R&D, RA projects for the pharmaceutical
industry.
- Pharmaceutical translation training. If you need to extend
your knowledge and understanding of pharmaceutical and chemical translation,
don't hesitate to contact me.
SPECIALIZATION:
·- CTD (All Modules)
- Drug Master Files (DMF, ASMF)
- CMC
- Pharmaceutical Manufacturing
·- GMP (GxP)
·- Validation (process, Analytical Methods)
·- Regulatory Affairs (RA)
·- Pharmacovigilance
· - Clinical
Trials
· - Pharmaceutical Inspections
· - Research and Development
(R&D)
· - Chromatography
· - General, Organic, Inorganic
Chemistry
· - Biochemistry
· - Pharmacology
· - Medical Devices
· - General Medicine
Ph.D. in Chemistry, BA in
Economics.
Should you require some additional information, feel
free to request my CV, diploma, etc.
Keywords: Russian, R&D, RA, GMP, Inspection, Clinical Trials, Biochemistry, Chromatography, Oncology, Regulatory Affairs. See more.Russian, R&D, RA, GMP, Inspection, Clinical Trials, Biochemistry, Chromatography, Oncology, Regulatory Affairs, Pharmacology, Pharmacovigilance, Medical Device, Medicinal Product, Clean Room, Oil&Gas, COA, Data Sheet, Specification, SIte Master File, Marketing Authorisation, Audits, Validation, Chemistry, Organic Chemistry, Pharmacokinetics, Marketing, Business Administration, Translation, Interpreting, Editing/proofreading, Website localization, Transcription, User Manual. See less.