Controlled room temperature

Storage at controlled room temperature (the earth is divided into four climate zones for this purpose), with sampling times in intervals of 3, 6, or 12 months. 

Room temperature Controlled room temperature Warm... 

In the absence of stability information that is applicable to a specific drug and preparation, the following maximum beyond-use dates are recommended for nonsterile compounded drug precautions that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated. ... 

Negative Feedback. Some of the neurotransmitter diffuses back to the surface of the nerve cell that released it. There are also receptors that tit the neurotransmitter here. When a neurotransmitter binds a receptor (called an autoreceptor) at the axon terminal of the nerve cell that released it, it tells the nerve cell that there s plenty of neurotransmitter already in the synapse. So don t release anymore This process is called negative feedback and is analogous to the way a thermostat works in your home to control room temperature. 

In the catalyst preparation area where the fire occurred, aluminum alkyl and isopentane are mixed in a batch blending operation in three 8000-gallon kettles. The flow rates of components are regulated by an operator at the control room. Temperature, pressure, and liquid level within the kettles are monitored by the control room operator. The formulated catalyst is stored in four 12,000-gallon vertical storage tanks within this process unit. Aluminum alkyl is a pyrophoric material and isopentane is extremely flammable. Each vessel was insulated and equipped with a relief valve sized for external fire. 

Compatibility/Stability- Esmolol, at a final concentration of 10 mg/mL, is compatible with the following solutions and is stable for 24 hours or more at controlled room temperature or under refrigeration 5% dextrose injection 5% dextrose in Lactated Ringer s injection 5% dextrose in Ringer s injection 5% dextrose and 0.9% or 0.45% sodium chloride injection Lactated Ringer s injection potassium chloride (40 mEq/L) in 5% dextrose injection 0.9% or 0.45% sodium chloride injection. 

The stability data for the pilot scale batch of Penclomedine is presented in Figure 21.5. The data indicate that this drug is fairly stable in various vehicles under consideration. Ahuman Phase I clinical batch in Neobee Oil was produced and its shelf-life surveillance at controlled room temperature has shown 3 years of stability. 

All middle phase microemulsion and solubilization studies were carried out in 20 ml centrifuge tubes with Teflon screw caps. Experiments were conducted at controlled room temperature of 22°C. Equal volumes of aqueous surfactant solution and oil (10.00 ml each) were placed in the centrifuge tube. The tube was shaken gently on a wrist action shaker for 20 minutes and allowed to stand for at least 12 hours to ensure equilibrium. The volume of each phase was carefully recorded to within 0.01 mis. The surfactant and oil concentrations were quantified in each phase for a few... 

Store at control room temperature, 20-25 °C, protect from light. 

T. A. Jung, R. R. Schlittler, J. K. Gimzewski, H. Tang and C. Joachim, Controlled room-temperature positioning of individual molecules Molecular flexure and motion, Science 271, 181 (1996). 

Erythromycin Minimum fill, water, and assay Collapsible tubes or in tight containers at controlled room temperature... 

Collapsible tubes or tight containers store at controlled room temperature Collapsible tubes or other well-closed containers... 

Tight containers, protected from light, and avoid prolonged exposure to temperatures exceeding 30 °C Collapsible tubes or tight containers store at 25 °C excursions permitted between 15 and 30 protect from freezing Collapsible tubes at controlled room temperature... 

Sodium sulfide pH (11.5-13.5) and assay Tight containers at controlled room temperature or in a cool place... 

The distribution rates for iodination of monosubstituted benzene derivatives have been reported. Under conditions of thermodynamic control (elevated temperature), meta substitution is observed. Under conditions of kinetic control (room temperature), a significant preference for para substitution is observed for compounds containing oriha- puru-directing substituent groups. Ortho substitution results when chelation of TTFA with the directing substituent permits intramolecular delivery of the electrophile. For example, methyl benzoate gives almost exclusively or/ho-lhallation (95%). 

The manufacturers recommend that methotrexate injection solutions be stored at controlled room temperature and protected from light. Injection solutions are administered undiluted (25 mg/mL) by IVbolus injection or infusion after dilution. Methotrexate solutions are susceptible to hydrolytic and photolytic degradation. On prolonged exposure to window-glass-filtered daylight, a yellow precipitate is formed. 

A maximum of 25%i RH at a controlled room temperature of 25° C or less is usually sufficient to avoid problems caused by atmospheric moisture. ... 

To illustrate the ARS form selection process, two pharmaceutical examples of ARS form selection are provided. Indinavir sulfate is the API for Crixivan , a specific and potent inhibitor of the HIV-1 protease used in the treatment of AIDS. Indinavir sulfate is produced as a crystalline ethanolate sulfate salt. If the material is stored in double polyethylene liners within fiber containers or repeatedly exposed to ambient conditions changes occur in both crystallinity and solvation. Using XRPD, KF, and RP-HPLC, conversion of the crystalline ethanolate to amorphous material or to a hydrate crystal form has been detected and degradation is observed. However, the material is stable if stored in a tightly sealed container impermeable to ethanol/moisture transport under an inert nitrogen atmosphere at a controlled room temperature.82,83 These storage conditions are not practical for a routinely used ARS. Therefore, the free base monohydrate form of indinavir sulfate was evaluated and selected as the ARS. This form of the API was demonstrated to be extremely stable under ambient conditions needed for routine analysis. 

They should be stored at controlled room temperature 15 to 30 (59 to 86 F) (52,53). Preserved in tight, light-resistant containers (3). 

A mixture of polysorbate 20 and PEG 400 in combination with povidone and butylated hydroxy anisole (BHA) solubilizes 75 mg bexarotene, a benzoic acid derivative that is a selective activator of the retinoid X receptor indicated for the treatment of T-cell lymphoma, in Targretin soft gelatin capsules. The dose of bexarotene is 300-750 mg (four to ten capsules) once daily and Targretin soft gelatin capsules should be stored at controlled room temperature. Targretin has been available in the United Kingdom (UK) since 2001, and is also available in the United States of America (USA). 

Calcitriol is a non-ionizable and water-insoluble calcium-regulator intended for the treatment of hypocalcemia. Calcitriol is formulated as a solution in a fractionated medium-chain triglyceride of coconut oil, along with the antioxidants BHA and butylated hydroxy toluene (BHT), as 0.25 pg and 0.5 pg Rocaltrol soft gelatin capsules, which have been available in the UK since 1996, and are also available in the USA. Rocaltrol is also available (USA only) as a 1 pg/mL oral solution formulated in a fractionated triglyceride of palm seed oil. Calcitriol is not available in Japan, but a similar molecule, falecalcitriol, is available and marketed as a conventional solid tablet formulation. The dose of calcitriol is 0.25-0.5 pg (one capsule) and the product should be stored at controlled room temperature. 

Lubiprostone is a water-insoluble heptanoic acid derivative used in the treatment of chronic idiopathic constipation in adults, and is solubilized in medium-chain triglyceride in 24 pg Amitiza soft gelatin capsules. The dose of lubiprostone is 24 pg (one capsule) twice daily with food. Amitiza should be stored at controlled room temperature and was approved in the USA in 2006. 

Corn oil solubilizes 250 mg of valproic acid, an anticonvulsant with an intrinsic water solubility of 1.3 mg/mL, in Depakene soft gelatin capsules available in the USA. In the UK, valproic acid is formulated as a solution in meditmi-chain triglycerides as 100-mg, 200-mg and 500-mg Convulex enteric coated soft gelatin capsules, where it has been available since 1991. The dose of valproic acid is 600 mg to 2500 mg (two to ten capsules) daily, and both products should be stored at controlled room temperature. 

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