‘Assay Not ess than 32.0% and not more than 44.0% of esters, calculated as bornyl acetate (C::H302) Angular Rotation Between -33° and ~45°. Heavy Metals (as Pb) Passes test. Refractive Index Between 1.468 and 1.473 st 20°. Solubility in Alcohol Passes test. Specific Gravity Between 0.398 and 0.912. ‘TESTS Assay Weigh accurately about 2 g, and proceed as directed ‘under Ester Determination, Appendix VI, using 98.15 as the equivalence factor (e) in the calculation. Angular Rotation Determine in a 100-mm tube as directed ‘under Optical (Specific) Rotation, Appendix IB. Heavy Metals Shake 10 mL of the oil with an equal volume ‘of water to which I drop of hydrochloric acid has been added, and pass hydrogen sulfide through the mixture until it is satu- rated, No darkening in color is produced in either the oil or the Refractive Index, Appendix IB Determine with an Abbé ot other refractometer of equal or greater accuracy: Solubility in Alcohol Proceed as directed in the general ‘method, Appendix VI. One mL dissolves in 1 ml of 90% alcohol. Occasionally the solution may become hazy upon fur- ther dilution, Specific Gravity Determine by any reliable method (see Gen: ‘eral Provisions Packaging and Storage Store in fll tight, preferably glas, ‘aluminum, orin-lined containers in a cool lace protected from light. Folic Acid 1N-[4-[[@-Amino-1,4-dihydro-4-oxo-6-pteridinyl methyl} amino[benzoyl}-L-glutamic Acid; N-[p-([(2-Amino-4-hydroxy: 6-pteridinylmethyllaminoJbenzoyliglutamic Acid; Pteroylghi- tamic Acid; Folacin 7 oe Teele N, No H oO 2 : on Akos ° Coeds Formal wt 4440 AS93031 DESCRIPTION Yellow or yellowish orange, odorless cxystals or crystalline powder. About 1.6 mg dissolves in I mL of wate. Its insoluble FCC 1V/ Monograph Specifications / 157 in acetone, in alcohol, in chloroform, and in ether, but dissolves in solutions of alkali hydroxides and carbonates. The pH of = suspension of 1 g in 10 mL of water is between about 4.0 and 48. Functional Use in Foods Nutrient; dietary supplement. REQUIREMENTS Identification ‘The ultraviolet absorption spectrum of a 1 in 100,000 solution of the sample in sodium hydroxide solution (1250) exhibits maxima and minima atthe same wavelengths 88 that of a similar solution of USP Folic Acid Reference Stan dard, concomitantly measured. The ratio Azz/Ass is between 2.80 and 3.00. ‘Assay Not less than 95.0% and not more than 102.05 of CiotsN;Og, calculated on the anhydrous bass Residue on Ignition Not more than 03%. Water Not more than 8.5% TESTS Assay Standard Solution Weigh accurately about 30 mg of USP Folie Acid Reference Standard, corrected for water content, and dissolve in an aqueous solvent containing 2 mL of ammonium hydroxide and 1 g of sodium perchlorate per 100 mL. Using the same solvent, adjust the volume quantitatively, secording ‘othe injection size tobe used in the Procedure, so that between 5 and 20 jg of Folic Acid is chromatographed. ‘Sample Solution Prepare as directed forthe Standard Solu tion, using an accuretely weighed quantity of the sample, and adjust to the same volume as the Standard Solution. “Mobile Phase Transfer 38.1 g of sodium perchlorate, 1.40 ‘2 of monobasic potassium phosphate, 7.0 mL of 1 N potassium hhydroxide, and 40 mL of methanol to 8 1000-mL. volumetric flask, dilute with water to volume, and mix. Adjust the pH to 7.2 ith LN potassium hydroxide Note: The methanol concentration may be varied to meet system suitability requirements and to provide a suitable lution time for Folic Acid Chromatographic System Typically a high-pressure liquid chromatograph, operated at room temperature, is ited with a 25- to 30-cm 4-mm stainless steel column packed with octade- «yl silane chemically bonded to porous silica or ceramic micro- particles Sto 10 um in diameter. The mobile phase is maintained ata pressure and flow rate capable of giving the required resolu- tion (see System Suitability Test) and a suitable elution time: 'An ultraviolet detector that monitors absorption at 254 mm is used System Suitability Solurion Prepare a solution containing about 1 mgimL each of USP Folic Acid Reference Standard and USP Caleium Formyltetahydrofolate Authentic Substance {nan aqueous solvent containing 2 mL of ammonium hydroxide and | g of sodium perchlorate per 100 mL. Filter the solution before use trough 2 membrane filter of I-yum porosity or fin ‘System Suitability Test Cheomatograph five injections of equal volume, up 19 25 yb, of the Standard Solution, and158 / Fcc 1 / Monograph Specifications ‘measure the peak response as directed in the Procedure. The relative standard deviation, calculated by the formula 100 x (standard deviation/mean peak response, for the peak response ‘does not exceed 2%, Inject a volume, up to 25 iL, ofthe System Suitability Solution in a simslar manner. The resolution fector, £, between calcium formyltetrahydrofolate and Folic Acid, cab culated by the formula given for R under Chromatography, Appendix IA, is not less than 36 Note: Fora particular column, resolution may be increased bby decreasing the amount of methanol inthe mobile pse. Procedure Introduce equal volumes, up t0 25 wy of the Sample Solution and Standard Solution into the chromatograph bby means of suitable sampling valve or high-pressure microsy ringe. Measure the responses for the major peaks obtained with the Sample Solution and the Standard Solution, Calculate the ‘quantity, in mg, of CigHigN;O, in the sample taken by the formula VC x (Pus), in which V is the volume of the Sample Solution, in mL; C is the concentration of USP Folic Acid Reference inthe Standard Solution, in mg/taL; and Py and Ps are the peak responses of the solutions from the Sample Solution and the Standard Solution, respectively. Residue on Ignition Ignite | as directed in the general ‘method, Appendix IIC Water Determine by the Kar! Fischer Turimetric Method, Appendix IIB, using a 200-mg sample. Packaging and Storage containers Store in well-closed,lightresstant Food Starch, Modified Modified Food Starch; Food Starch-Mosified DESCRIPTION Modified food starches are products of the treatment of any of ‘or ro0t-based native starches (e.., comm, Sorghum, tapioca, sag0, etc) wit small amounts of certain chemical agents, which modify the physical characteristics of the native starches to produce desirable properties. Starch molecules ae polymers of anhydroglucose and occur in both linear and branched form. The degree of polymerization and, accordingly, the molecular weight of te nataally curring starch molecules vary radically, Furthermore, they vary inthe tio of branched chain polymers (amylopectin) to linear chain polymers amylose), both within a given type of starch and from ‘one type to another, These factors, in addition to any type of chemical modification used, affect the viscosity, texture, and ability ofthe starch sols significantly Starch is chemically modified by mild degradation reactions orby reactions between the hydroxyl groups of the native starch 1 the reactant selected. One or more of the following processes are used: mild oxidation (bleaching), moderate oxidation, acid andor enzyme depolymerization, monofunctional esterification, polyfunetional esterification (cross-linking), monofunctional etherifcation, alkaline gelatinization, and certain combinations ‘of these treatments. These methods of preparation can be used 5 a basis for classifying the starches thus produced (see ADDI- ‘TIONAL REQUIREMENTS below). Generally however, the prod- ucts are called Modified Food Starch, or Food Starch- Modified. Modified food starches are usually produced as white ornearly white, tasteless, odorless powders; as intact granules; and if pregelatinized (ie, subjected to heat treatment in the presence of Water), as flakes, amorphous powders, or coarse particles. Modified food starches are insoluble in alcohol, in ether, and in chloroform. If not pregelatinized, they ae practically insolu- ble in cold water. Upon heating in water, the granules usually begin to swell at temperatures berwcen 45° and 80°, depending on the botanical origin and the degree of modification. They gelatinize completely at higher temperatures, Pregelatinized Starches hydrate in cold water. Funetional Use of Foods Thickener; colloidal stabilizer; binder REQUIREMENTS Labeling Indicate the presence of sulfur dioxide if the residual concentration is greater than 10 mg/kg Identification ‘A, Suspend about 1 g of the sample in 20 mL of water, and add a few drops of iodine TS. A dark blue to red color is produced. B. Place about 2.5 g of the sample in a boiling ask, add 10 iL of dilute hydrochloric acid (3%) and 70 mL of water, mix, reflux for about 3h, and cool. Add 0.5 ml. of the resulting solution to $ mL of hot alkaline cupric tarate TS, A copious red precipitate is produced C. Examine a portion ofthe sample witha polarizing micro- scope in polarized light under erossed Nicol prisms, The typical polarization cross is observed, except in the case of pregelati nized starches. Arsenic (as As) Not mote than 3 mks. Crude Fat Not more than 0.15% Heavy Metals (as Pb) Not more than 0.002% Lead Not more than 1 mghke. Loss on Drying Cereal starch: not more than 15.05; potato starch: not more than 21,0%; sago and tapioca starch: not more than 18.0%. pH of Dispersions Beween 3.0 and 9.0. Protein Not more than 0.5%, except not more than 1% in ‘modified high-amylose starches Sulfur Dioxide Not more than 0.005%, ADDITIONAL REQUIREMENTS The modified food starches listed below according to method of preparation must mest all of the above REQUIREMENTS in addition to the specified methods of Treatment (the reagent for which, if not specifically limited, should not exceed the amount