QC-CA-29FBL1
29.3B12.2L 4
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Certificate of Analysis
Reference Material
Lipomed Document QC-CA-29FBL1
Version: [Link].2014 Supersedes: [Link].2009
Product name: 1 ml Heroin solution (1 mg free base/1 ml acetonitrile)
(5α,6α)-7,8-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol diacetate
; 3,6-Diacetylmorphine
Lot Nr: 29.3B12.2L4 Release date: February 27, 2009
Art. Nr: M-29-FB-1LA Last testing date: October 08, 2015
Retest date: October 2017
Bulk Product Information: 29.3B12.2
Chemical formula: C21H23NO5 Molwt: 369.42
CAS Registry Nr: 561-27-3
TEST SPECIFICATIONS RESULTS
1. Appearance clear colorless solution conforms
2. Identity HPLC Rt corresponds to Rt of Rt standard = 13.2 min
reference standard ( 0.5 min) Rt test = 13.1 min
3. Purity HPLC > 98.5 % 99.196 0.024 %
4. Concentration of 1.000 0.050 mg/ml 1.015 0.021 mg/ml (mean value)
calibrated ampoule free base free base
5. Solvent purity (GC) acetonitrile > 99.9 % > 99.9 %
6. Extractable volume > 1 ml conforms
FOR ANALYTICAL PURPOSES ONLY: NOT FOR HUMAN OR ANIMAL USE!
Storage conditions: For maximum stability store air-tight at 2 - 8 °C in a dark location.
Lipomed certifies that this standard meets the specifications stated in this certificate and warrants this
product to meet the stated acceptance criteria through the retest date when stored unopened as
recommended. The product should be used shortly after opening to avoid concentration changes due to
evaporation. Warranty does not apply to ampoules stored after opening.
Issued by Dr. L. Prévot Date sign: Arlesheim,
October 08, 2015
Lipomed AG, Switzerland is GMP/GDP and ISO 9001:2008 (CH-37199) certified for production
and distribution of pharmaceuticals and ISO/IEC 17025:2005 (AT-1760) accredited for testing
of analytical reference standards and ISO Guide 34:2009 (AR-1761) accredited for reference
material production. All products distributed by Lipomed affiliates are manufactured by
Lipomed AG and distributed under protocols of Lipomed AG.
QC-CA-29FBL1
29.3B12.2L 4
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Standard Solution Calibration:
Bulk Reference Prepared concentration Analyzed concentration
Ampoules
Solutions in mg/ml in mg/ml
Reference 1 1.013 mg/ml First sample 1.009 mg/ml
Reference 2 1.012 mg/ml Second sample 1.016 mg/ml
Third sample 1.018 mg/ml
Lot to Lot Consistency:
Standard solution Lot Number Concentration
Actual Lot 29.3B12.2L4 1.015 0.021 mg/ml free base
Previous Lot 29.3B12.2L3 1.034 0.023 mg/ml free base
HPLC Data:
Lipomed AG, Switzerland is GMP/GDP and ISO 9001:2008 (CH-37199) certified for production
and distribution of pharmaceuticals and ISO/IEC 17025:2005 (AT-1760) accredited for testing
of analytical reference standards and ISO Guide 34:2009 (AR-1761) accredited for reference
material production. All products distributed by Lipomed affiliates are manufactured by
Lipomed AG and distributed under protocols of Lipomed AG.
QC-CA-29FBL1
29.3B12.2L 4
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GENERAL INFORMATION
Quality Documentation:
This certificate is designed in accordance with ISO Guide 31 (Reference Materials – Contents of Certificates and Labels)
and ISO Guide 35 (Reference Materials – General and Statistical Principles for Certification).
Quality Standards:
ISO 9001:2008 Quality Management System. Manufacturing, analysis, packaging and distribution of
Analytical Reference Materials and Pharmaceuticals. IQNet/SQS Certification: 37199
ISO/IEC 17025:2005 General requirements for the competence of Testing Analytical Reference Standards.
ACLASS Certificate number: AT-1760
ISO Guide 34:2009 General requirements for the competence of Reference Material Producer.
ACLASS Certificate number: AR-1761
Quality Control Assessment:
The product quality is controlled by regularly performed quality control tests (retests).
Intended Use:
The product covered by this certificate is designed for calibration or for use in quality control procedures for the specified
chemical compound listed page 1. This product can be used for quantification and/or identification. If dilution is required
use only diluent compatible with all certified analyses in this preparation. All solutions should be thoroughly mixed prior to
use.
Expiration/Retest dates:
Expiration date/Retest date of the unopened ampoule stored at the recommended storage condition is the last day of the
month listed page 1.
A retest is performed 6 months prior to the stated retest date. Upon successful retesting, a new retest date or expiration
date is set for the product. The certificate of analysis is then updated and made available on our web-site. A maximum of
5 years after the release date is given. Upon successful retesting after these 5 years, an expiry date of 2 years is stated.
Uncertainty, concentration and Expiration/Retest dates of the Reference Material are based on the unopened ampoule
being stored according to the recommended condition found in the storage field.
Gravimetric preparation:
All balances are calibrated annually by an ISO/IEC 17025 accredited calibration service. Calibration verification is
performed weekly with certified traceable weights. Each balance has been assigned a minimum weighing.
Purity:
Purity and/or chemical identity are determined by one or more of the following techniques: HPLC, GC/FID, LC/MS,
IR, UV, NMR, Karl Fischer, melting point and optical rotation if applicable
Purity of isomeric compounds is reported as the sum of the isomers
Purity values are rounded up to the third decimal place
The content is already corrected from the salt form, the purity, residual water and residual solvents.
Uncertainty Statistics and Confidence limits:
The uncertainties are determined in accordance with ISO Guide 34 and 17025. The certified combined stressed
uncertainty value (includes gravimetric uncertainty, homogeneity between ampoules uncertainty, storage stability
uncertainty and shipping stability uncertainty) were combined using the following formula:
2 2 2 2
𝑈𝑐(𝑦) = 𝑘 √𝑈𝑐ℎ𝑎𝑟𝑎𝑐𝑡𝑒𝑟𝑖𝑧𝑎𝑡𝑖𝑜𝑛 + 𝑈ℎ𝑜𝑚𝑜𝑔𝑒𝑛𝑒𝑖𝑡𝑦 + 𝑈𝑠𝑡𝑜𝑟𝑎𝑔𝑒 𝑠𝑡𝑎𝑏𝑖𝑙𝑖𝑡𝑦 + 𝑈𝑠ℎ𝑖𝑝𝑝𝑖𝑛𝑔 𝑠𝑡𝑎𝑏𝑖𝑙𝑖𝑡𝑦
f
K is a coverage factor of 2, which gives the level of confidence of approximately 95%.
The packaged amount is the minimum sample size for which uncertainty is valid. The ampoules are over-filled to ensure
that the minimum packaged amount can be sufficiently transferred.
Homogeneity:
Homogeneity of the lot is confirmed by a duplicate analysis of 12 ampoules. 4 ampoules are taken in each early, middle
and late fill position. The analyzed concentration in each early, middle and late fill position is the average value obtained
from duplicate analysis of 4 ampoules
Stability:
The manufacturer guarantees the stability of this solution through the date stated on page 1 of the certificate when
handled and stored accordingly to the conditions stated page 1.
Legal Notice and Limit of Liability:
This product is for routine laboratory analysis and research proposal only. Due to the hazardous nature, only trained
personnel should handle this product. The company’s liability will be limited to replacement of product or refund or
purchase price. Notice of claims must be made within thirty (30) days from date of delivery.
Lipomed AG, Switzerland is GMP/GDP and ISO 9001:2008 (CH-37199) certified for production
and distribution of pharmaceuticals and ISO/IEC 17025:2005 (AT-1760) accredited for testing
of analytical reference standards and ISO Guide 34:2009 (AR-1761) accredited for reference
material production. All products distributed by Lipomed affiliates are manufactured by
Lipomed AG and distributed under protocols of Lipomed AG.