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Product documentation

Download the technical data sheet for any product, download verified documents, or request the specification, Certificate of Analysis, Safety Data Sheet and regulatory documents you need for your evaluation.

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Technical data sheets to download

62

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Showing 62 of 62 products

Apomorphine

CAS 58-00-4 · Pharmaceutical Ingredients

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Method of analysis (MOA)
  • Residual solvents statement (ICH Q3C)
  • Elemental impurities statement (ICH Q3D)
  • Nitrosamine risk assessment
  • End-use / end-user declaration
Request 8 documents
Dexamethasone

CAS 50-02-2 · Pharmaceutical Ingredients

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Method of analysis (MOA)
  • Residual solvents statement (ICH Q3C)
  • Elemental impurities statement (ICH Q3D)
  • Nitrosamine risk assessment
  • End-use / end-user declaration
Request 8 documents
Enclomiphene

CAS 15690-57-0 · Pharmaceutical Ingredients

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Method of analysis (MOA)
  • Residual solvents statement (ICH Q3C)
  • Elemental impurities statement (ICH Q3D)
  • Nitrosamine risk assessment
  • End-use / end-user declaration
Request 8 documents
HCG

Pharmaceutical Ingredients

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Method of analysis (MOA)
  • Residual solvents statement (ICH Q3C)
  • Elemental impurities statement (ICH Q3D)
  • Nitrosamine risk assessment
  • End-use / end-user declaration
Request 8 documents
IGF-1 LR3

CAS 143045-27-6 · Peptides & Peptide Materials

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Analytical data (chromatograms / spectra)
  • Method of analysis (MOA)
  • TSE/BSE statement
  • Stability and storage statement
  • End-use / end-user declaration
Request 8 documents
Phentermine

CAS 122-09-8 · Pharmaceutical Ingredients

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Method of analysis (MOA)
  • Residual solvents statement (ICH Q3C)
  • Elemental impurities statement (ICH Q3D)
  • Nitrosamine risk assessment
  • End-use / end-user declaration
Request 8 documents
Sildenafil

CAS 139755-83-2 · Pharmaceutical Ingredients

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Method of analysis (MOA)
  • Residual solvents statement (ICH Q3C)
  • Elemental impurities statement (ICH Q3D)
  • Nitrosamine risk assessment
  • End-use / end-user declaration
Request 8 documents
Tadalafil

CAS 171596-29-5 · Pharmaceutical Ingredients

Price quoted on request

Technical data sheet (PDF)Product sheet
  • Product specification
  • Certificate of Analysis (COA)
  • Safety Data Sheet (SDS)
  • Method of analysis (MOA)
  • Residual solvents statement (ICH Q3C)
  • Elemental impurities statement (ICH Q3D)
  • Nitrosamine risk assessment
  • End-use / end-user declaration
Request 8 documents

available to download · available on request

Guide to document types

What each document contains, who issues it and what it proves. Quality & Documentation guidance →

Quality and analytical6 document types

Product specification

Issued by: Manufacturer / Red Chem Biotech

Defines the tests, methods and acceptance criteria that a named material and grade must meet.

Contains

  • Material name, grade and identifiers (CAS, formula)
  • Each test parameter with method reference and acceptance limit
  • Specification number, version and effective date
  • Issuing legal entity and approval signature

Does not prove: That any particular batch meets it — that is the job of a Certificate of Analysis.

Certificate of Analysis (COA)

Issued by: Manufacturer / Testing laboratory / Red Chem Biotech

Batch-specific record of the results obtained when a batch was tested against its specification.

Contains

  • Batch or lot number, manufacture and retest/expiry dates
  • Specification reference the batch was tested against
  • Result for every specified test, with units and limits
  • Name of the testing laboratory and an authorised signature

Does not prove: Anything about a different batch, or that the issuer manufactured the material.

Method of analysis (MOA)

Issued by: Manufacturer / Red Chem Biotech

Step-by-step analytical procedures behind each specification test, so the buyer can reproduce them.

Contains

  • Method number and the specification it supports
  • Equipment, reagents, standards and system suitability
  • Sample preparation, procedure and calculation
  • Validation or verification status

Does not prove: That a method is validated unless validation data are referenced.

Analytical data (chromatograms / spectra)

Issued by: Testing laboratory / Manufacturer

Raw or processed analytical data such as HPLC chromatograms, mass spectra or NMR spectra for a batch.

Contains

  • Material and batch the data relate to
  • Method, instrument and conditions used
  • Data with peak identification or interpretation
  • Laboratory, analyst and date

Does not prove: Compliance with a specification unless tied to one by a signed COA.

Technical data sheet (TDS)

Issued by: Red Chem Biotech / Manufacturer

Summary of identity, typical properties, composition, handling and packaging for a material.

Contains

  • Identity and composition
  • Typical properties clearly marked as typical
  • Storage and packaging
  • Revision date

Does not prove: Batch quality — typical values are not specification limits.

Stability and storage statement

Issued by: Manufacturer / Red Chem Biotech

Storage conditions, retest period or shelf life, and the stability data that support them.

Contains

  • Storage condition studied
  • Duration and attributes monitored
  • Assigned retest period / shelf life
  • Data reference

Does not prove: Stability under conditions that were not studied.

Safety1 document types

Safety Data Sheet (SDS)

Issued by: Manufacturer / Red Chem Biotech

Hazard, handling, storage, exposure-control and transport information in the 16-section GHS format.

Contains

  • Product identifier and responsible supplier with emergency contact
  • GHS hazard classification, pictograms and statements
  • Handling, storage, exposure controls and transport information
  • Revision number and date

Does not prove: Purity, quality or regulatory status. An SDS is not a quality certificate.

Compliance statements6 document types

TSE/BSE statement

Issued by: Manufacturer / Red Chem Biotech

Declares whether animal-derived materials are used, and if so their species, origin and EDQM/EMA compliance.

Contains

  • Use of animal-origin materials (yes/no)
  • Species, tissue and country if used
  • Reference to EMA/410/01 or CEP
  • Signed by the manufacturer

Does not prove: Anything the manufacturer has not declared and evidenced.

Residual solvents statement (ICH Q3C)

Issued by: Manufacturer / Red Chem Biotech

Lists solvents used or produced in manufacture and how they are controlled against ICH Q3C limits.

Contains

  • Solvents used with ICH class
  • Control strategy (tested / justified)
  • Limits applied
  • Signed by the manufacturer

Does not prove: Batch levels, unless test results are given on the COA.

Elemental impurities statement (ICH Q3D)

Issued by: Manufacturer / Red Chem Biotech

Risk assessment of elemental impurities (catalysts, equipment, water) against ICH Q3D permitted exposures.

Contains

  • Elements considered and their sources
  • Risk-assessment conclusion
  • Testing performed, if any
  • Signed by the manufacturer

Does not prove: Suitability for a route of administration not assessed.

Nitrosamine risk assessment

Issued by: Manufacturer / Red Chem Biotech

Evaluation of the risk of N-nitrosamine formation or contamination, as expected by EMA and FDA for APIs.

Contains

  • Scope (API, process, site)
  • Risk factors evaluated
  • Conclusion and any confirmatory testing
  • Date and signature

Does not prove: Absence of nitrosamines unless confirmatory testing is reported.

Allergen and GMO statement

Issued by: Manufacturer / Red Chem Biotech

Declares allergen content and genetically modified origin for food, supplement and nutraceutical ingredients.

Contains

  • Allergen matrix (EU Annex II / US FALCPA)
  • GMO status and source organism
  • Cross-contact controls
  • Signed by the manufacturer

Does not prove: Absence of allergens not listed in the matrix.

REACH / chemical inventory statement

Issued by: Manufacturer / Authority

Registration or exemption status under EU REACH and other chemical inventories (TSCA, etc.).

Contains

  • Inventory and registration numbers
  • Tonnage band or exemption basis
  • Legal entity responsible

Does not prove: Status in inventories not listed.

Regulatory and GMP4 document types

GMP certificate / manufacturing licence

Issued by: Authority

GMP certificate, drug manufacturing licence or equivalent issued by a competent authority to the manufacturing site.

Contains

  • Issuing authority
  • Legal entity and site address
  • Certificate or licence number and scope
  • Validity dates and verification route

Does not prove: Anything outside the named site, scope or validity period.

DMF / CEP / ASMF letter of access

Issued by: Manufacturer / Authority

Authorisation for a regulator to reference the manufacturer's Drug Master File or CEP in the buyer's filing.

Contains

  • DMF/CEP number and holder
  • Buyer and product being authorised
  • Signature of the holder

Does not prove: That the DMF has been reviewed or accepted unless stated by the authority.

Import / export permit

Issued by: Authority

Licences required for controlled or scheduled substances in the exporting and importing countries.

Contains

  • Permit number and issuing authority
  • Substance and quantity
  • Consignor and consignee
  • Validity

Does not prove: Permission for any other substance, quantity or party.

Other certificate

Issued by: Authority / Manufacturer

Other certificates, e.g. Halal, Kosher, ISO or organic certification for a named site or product.

Contains

  • Certifying body
  • Entity, site and product scope
  • Validity dates

Does not prove: Anything outside the certificate's scope.

Supplier qualification2 document types

Quality agreement

Issued by: Red Chem Biotech / Buyer

Agreement defining quality responsibilities, change notification, complaints and audit rights between parties.

Contains

  • Parties and scope
  • Responsibilities matrix
  • Change-control and deviation notification
  • Signatures

Does not prove: Compliance with the agreement in practice.

Supplier qualification questionnaire

Issued by: Red Chem Biotech

The buyer's questionnaire on legal identity, quality system, supply chain and continuity, completed by the supplier.

Contains

  • Company identity
  • Quality-system description
  • Supply-chain roles and sites
  • Signature and date

Does not prove: Anything not supported by referenced evidence.

Trade and shipment4 document types

Quotation / proforma invoice

Issued by: Red Chem Biotech

Written commercial offer stating price, quantity, specification, Incoterms, lead time, documents and validity.

Contains

  • Quotation number and validity
  • Product, specification reference, quantity and price
  • Incoterms, payment and lead time
  • Documents supplied with the shipment

Does not prove: Regulatory eligibility of the buyer or destination.

Packing list

Issued by: Red Chem Biotech

Shipment contents by package: batch, quantity, gross/net weight and storage conditions.

Contains

  • Invoice / order reference
  • Batch numbers and quantities per package
  • Weights and dimensions
  • Storage and handling marks

Does not prove: Quality of the contents.

Certificate / declaration of origin

Issued by: Authority / Red Chem Biotech

Country of origin of the goods. Formal certificates are issued by a chamber of commerce; the supplier's declaration supports it.

Contains

  • Exporter and consignee
  • Goods description and HS code
  • Country of origin
  • Issuing body or declarant signature

Does not prove: Quality or regulatory status.

Dangerous goods declaration

Issued by: Red Chem Biotech

Shipper's declaration required when a material is classified as dangerous goods for transport (IATA/IMDG/ADR).

Contains

  • UN number and proper shipping name
  • Class and packing group
  • Quantity and packaging
  • Signed by trained shipper

Does not prove: Anything beyond transport classification.

Buyer declarations1 document types

End-use / end-user declaration

Issued by: Buyer

Buyer's signed statement of the legal entity, intended use and destination, required for compliance-gated materials.

Contains

  • Buyer legal entity and registration
  • Intended use and end user
  • Destination and no-re-export undertaking
  • Authorised signature

Does not prove: That the use is lawful in the destination — permits may still be required.