OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to alternate L-Glutamine (CAS RN 56-85-9 / 5569-98-2) and DL-Glutamine (CAS RN 6899-04-3 / 585-21-7). Glutamine is a nonessential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from glutamic acid and ammonia. It is the principal carrier of nitrogen in the body and is an important energy source for many cells. Glutamine exists in two isoforms, L-glutamine and D-glutamine. The form found in foods and supplements is L-glutamine. While L-glutamine is used to make proteins and perform other functions, D-glutamine appears to be relatively unimportant in living organisms. Glutamine is used for nutritional supplementation and for treating dietary shortage or imbalance. It is also used to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients ≥ 5 years old. It is an amino acid commonly found as a component in total parenteral nutrition. L-glutamine is also indicated for the treatment of short bowel syndrome (SBS) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication. A glutamine-based oral suspension is under investigation for the treatment of oral mucositis associated with cancer chemotherapy. Glutamine is available as a powder, tablet, and syrup for oral administration, and as a solution for intravenous (IV) administration. It is marketed under the trade names Endari®, NutreStore®, and GNC L-Glutamine 1000® among others. Generic formulations are available. It is also available in combination products.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Glutamine, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.