OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Saccharin sodium (CAS RN 128-44-9), Saccharin sodium dihydrate (CAS RN 6155-57-3), Saccharin calcium hydrate (CAS RN 6381-91-5), Saccharin potassium (CAS RN 10332-51-1), Saccharin potassium dihydrate (CAS RN 292158-09-9), Saccharin calcium (CAS RN 6485-34-3), Saccharin magnesium (CAS RN Not Available), Saccharin ammonium (CAS RN 6381-61-9), Saccharin dihydrate (CAS Not Available), Saccharin hydrochloride (CAS Not Available), Saccharin sodium hydrate (CAS RN 82385-42-0), Saccharin and its salts are intense sweeteners. They are used in pharmaceuticals and in foods and beverages and are heat stable. They have no food value. The salts are more often used than saccharin itself, as they are considered to be more palatable. Saccharin is one of the oldest artificial sweeteners on the market. In fact, it has been used to sweeten foods and drinks for over 100 years. Saccharin’s primary use is as a calorie-free sweetener. It is one of the most affordable low-calorie sweeteners available, which may help weight loss, cavity prevention, and blood sugar regulation. Saccharin is mainly available commercially in following forms; the acid, the sodium salt (typically the dihydrate; CAS 6155-57-3), the calcium salt (CAS 6381-91-5), and the potassium salt (CAS 10332-51-1).

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 and the Permitted Daily Exposure (PDE) value.

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 Saccharin, just click the ADD TO CART button.

HBEL

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