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Pharmaceutical residual solvents, USP <467> singles

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Pharmaceutical residual solvents, USP <467> singles
Standards Organische Standards
The United States Pharmacopeia (USP)<467> residual solvents is a widely used compendial method intended for identifying and quantifying residual solvents in drug substances, drug products, and excipients.

In an attempt to better mirror the International Conference on Harmonization (ICH)guidelines, the USP has adopted a more comprehensive methodology in residual solvent testing-the current USP30/NF25. The ICH publishes a guideline (Q3C) listing the acceptable amounts of solvent residues that can be present. In the ICH guideline, residual solvents are summarised by class according to their toxicity.


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Terms & Conditions

These terms and conditions cover all sales of products and services by VWR International Ltd (VWR) in the United Kingdom and any information and advice given whether charged for or not, unless otherwise agreed by VWR in writing. These terms and conditions apply to the exclusion of any other terms submitted by the customer or which are implied by any trade, custom, practice or course of dealing.

Customer Accounts

VWR’s products can be hazardous and all customers are required to comply with the VWR account application procedures which are available on request. VWR reserves the right immediately to cancel any orders from customers who have not complied in full with these procedures.

Ordering

The customer’s order for the products and/or services is an offer by the customer to purchase those products and/or services in accordance with these terms and conditions and shall only be deemed accepted when VWR issues written acceptance of the order, at which point the contract between the customer and VWR for the supply of those products and/or services, comes into existence (contract).

Any additional or special terms included by VWR in its written acceptance shall form part of the contract. The terms and conditions of the contract apply equally to the supply of both products and services except where application to one or the other is specified.

Should VWR need to supply products and/or services of different specifications, sources, and pack size to that published or ordered by the customer, VWR shall do so only after consultation with and agreement by the customer.

Prices/Charges

VWR has the right to change the prices shown in catalogues and price lists at any time and to invoice at prices current at the date of receipt of an order.

Notwithstanding the foregoing paragraph, if there is a change of more than 3% to the rate of exchange of Sterling against foreign currencies including, but not limited to, the Euro and US Dollar since the date of receipt of an order then VWR may require the customer to renegotiate the prices relating to the relevant order.  Should VWR and the customer be unable to agree new prices within 7 days of receipt by the customer of a request in writing by VWR to renegotiate the price then VWR may terminate the contract with immediate effect by giving written notice to the customer.

‘Price on application’ (POA) quotations and all other quotations do not constitute offers and will be valid for 30 days from the date of the quotation, unless otherwise notified by VWR.

All prices in catalogues and quotations are net of Value Added Tax and any other taxes or duties. The prices exclude costs of packaging, insurance and transport which will be charged separately, if applicable.

VWR has the right to impose a minimum order charge at its discretion and such amount shall be notified to the customer in writing by VWR.

Payment

Unless otherwise agreed in writing payment in full in cleared funds is due from the customer within 30 days from date of invoice. Time for payment is of the essence.

VWR has the right to charge interest on all overdue sums at the rate of five percent per annum over the base lending rate of the Bank of England calculated from the due date until the date of actual payment.

Customers who exceed their credit limits will be asked to pay in advance for additional products and/or services until the account is settled.

VWR may at any time, without limiting any other rights and remedies that it may have, set off any amount owing to it by the customer under the contract against any amount payable by VWR to the customer (whether under the contract or a separate agreement).

Delivery

VWR shall deliver to the address set out in the order (delivery location) at any time after it gives notification that the products are ready for delivery. Delivery is completed when the products are unloaded at the delivery location (or immediately before if the customer is responsible for unloading in accordance with this contract).

Where delivery or performance dates are stated by VWR these are estimates only and time is not of the essence; however, if VWR needs to change such dates it will do so only after providing information to the customer and having regards to the customer’s stated objectives.

Delivered products will remain the property of   VWR until the customer has paid for them.

VWR has the right to deliver an order in instalments (which may be invoiced and paid for separately). Any delay or defect in an instalment does not give the customer the right to cancel other instalments.

Any claims for shortages must be made within 7 days of a delivery.

Any claims for non-ordered items or non-delivery must be made within 7 days of receiving the invoice.

Return of Damaged or Unsuitable Goods

No goods may be returned to VWR without the authorisation of VWR.

Authorisation to return products damaged during delivery must be requested within 3 days of delivery. VWR has the right to repair and return damaged products.

Authorisation for the return of products which fail to meet current published manufacturer’s specifications must be requested in writing within 28 days of delivery. VWR will assist customers, at customers’ expense, to obtain any manufacturer’s warranty consistent with that granted to VWR.

Authorisation for the return of products, other than those damaged during delivery, delivered in error or those that do not meet specification, must be requested within 10 days of delivery. Credit (less a handling charge of 15% of the invoice value of all products returned subject to a minimum charge of £30) will be given for those products authorised for return which are unused and in re-saleable condition other than those in the categories shown:-

  • open chemicals or diagnostics
  • refrigerated or other perishables
  • items with an expired shelf life or an expiration date too short for resale
  • any article that has been delivered direct by a third-party supplier
  • discontinued items
  • items not purchased from VWR

Authorisation will be subject to the condition that the products are returned to VWR Customer Service Centre or to the manufacturer or other source and by the method advised by VWR.

Articles that have been delivered on VWR’s behalf by a third-party supplier will not be accepted back at the VWR Customer Service Centre.

Supply of services

VWR shall provide services to the customer in accordance with the specification agreed between them from time to time.  Such services will be provided with all reasonable care and skill.

The customer shall cooperate with VWR in all matters relating to the services, provide all such access and information as is necessary and obtain any licences permissions and consents required before commencement of the services.

If VWR’s performance of the services is prevented or delayed by any act or omission of the customer, VWR shall without limiting its other rights or remedies, have the right to suspend performance of the services until the customer remedies the position and VWR shall not be liable for any losses or costs arising from such delay.

Health, Safety and Liability

Risk in products will pass at the time of delivery to the customer.
The customer is responsible for unloading and transporting large and/or heavy items from delivery vans and for supervising the unloading of all other products delivered.

In view of the hazards of certain chemicals and apparatus the customer must ensure that the products purchased are in a safe condition and that a safe system of work is in place taking into account all available information. None of the products sold are intended for human consumption unless otherwise clearly stated.
In view of the wide range of uses of chemicals and apparatus, the customer will be solely responsible for determining the suitability and specification of products, services, information and advice for its purposes.

Nothing in this contract shall limit or exclude VWR’s liability for death or personal injury caused by its negligence, fraud, fraudulent misrepresentation, or any other matter in respect of which it would be unlawful for VWR to exclude or restrict liability. Subject to this, in view of the responsibilities of the customer set out in the above paragraphs:

  • VWR shall under no circumstances whatsoever be liable to the customer (whether in contract, tort (including negligence), breach of statutory duty or otherwise), for any loss of profit, or any indirect or consequential loss arising in connection with the supply of products under this contract; and
  • the total liability of VWR for any loss or damage suffered by a customer in connection with the supply of the products under this contract is limited to the invoice price of the products in relation to which loss or damage is claimed.

Any liability accepted by VWR under this contract is in lieu of any terms implied by law as to the quality or fitness for any particular purpose of the products and/or the standard of the services and all such implied terms are, to the fullest extent permitted by law, excluded from the contract between VWR and the customer. The customer shall indemnify VWR against any claims made against VWR by the customer’s employees, contractors or agents.

Intellectual property rights

The customer is required to ensure that the use of any products supplied by VWR does not infringe the intellectual property rights of any third party and the customer shall indemnify VWR against any claims made against VWR by any third party in relation to any such infringement or alleged infringement.

All intellectual property rights arising out of or in connection with the services shall be owned by VWR.

Termination

Without limiting its other rights and remedies, VWR may terminate the contract with immediate effect or suspend deliveries of the products, by giving written notice to the customer if the customer has failed to pay any amount owed to VWR on its due date for payment and remains in default for 14 days after notification to make payment, or if the customer has suffered or is likely to suffer an insolvency event or its financial position deteriorates to such an extent that in VWR’s opinion, the customer’s capacity adequately to fulfill its obligations under the contract is in question.

On termination of the contract for any reason the customer shall immediately pay to VWR all of its outstanding unpaid invoices and interest.

Confidentiality

Each of VWR and the customer undertakes to the other that it shall not disclose to any person any confidential information concerning the business, affairs, customers or suppliers of the other except to its employees or advisers who need to know the information in order to carry out its obligations under this contract, or as may be required by law, a court of competent jurisdiction or any governmental or regulatory authority.

Governing law

This contract shall be governed by and construed in accordance with the laws of England and Wales and each of VWR and the customer irrevocably agrees with the other that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute arising under or in connection with it.

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