Product Description

Nicotine Polacrilex/Resinate (96055-45-7)

Nicotine polacrilex/resinate is a form of nicotine that is bound to a polymer, which allows it to be released slowly over time. This makes it a useful tool for nicotine replacement therapy (NRT), as it can help smokers to gradually reduce their nicotine intake and eventually quit smoking altogether.

Nicotine polacrilex/resinate is available in a variety of forms, including gum, lozenges, and patches. The gum is the most common form, and it is used by chewing the gum slowly until a tingling sensation is felt in the mouth. The lozenges are also chewed slowly, and they can be held in the mouth for up to 30 minutes. The patches are applied to the skin and deliver nicotine over a period of 16 hours.

Nicotine polacrilex/resinate is generally safe for most people to use, but it can cause some side effects, such as nausea, vomiting, and diarrhoea. It is important to talk to your doctor before using nicotine polacrilex/resinate, especially if you have any health conditions.

If you are trying to quit smoking, nicotine polacrilex/resinate can be a helpful tool. It can help you to manage cravings and withdrawal symptoms, and it can increase your chances of success in quitting smoking.

Here are some additional information about nicotine polacrilex/resinate:

·         It is available over-the-counter or by prescription.

·         The recommended dose is 2 mg per piece of gum or lozenge, or 15 mg per patch.

·         You should not use more than 24 mg of nicotine polacrilex/resinate per day.

·         You should not use nicotine polacrilex/resinate if you are pregnant or breastfeeding.

·         You should not use nicotine polacrilex/resinate if you have any of the following health conditions: heart disease, high blood pressure, stroke, diabetes, seizures, or an ulcer.

Identification

Molecular Formula   :     [ (C4H6O2)x(C10H10)y ] (C10H14N2)

Cas No.                       :     96055-45-7

Regulatory Documents

USDMF                      :     

EDMF                         :     

CEP                            :     

Batch Size                 :     50 Kgs.

Pharmacopoeial Compliance : USP, EP

Specifications

Appearance            :     Fine powder with off-white colour, free from contamination

Nicotine Release   :     ≥ 70 % released in 10 minutes

Loss on drying       :     ≤ 7.0 %

Assay

Nicotine content   :     95 % – 115 % of labeled claim on anhydrous basis (i.e. 19.0 % to 23.0 % Nicotine content)

Chromatographic purity By HPLC

Largest identified impurity                 :      Not more than 0.30 %

Largest Unidentified impurity            :     Not more than 0.10 %

Total impurity                                       :     Less than 0.80 %