ANALYTICAL APPARATUS

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Description

DISSOLUTION TEST

  • Description
    Equipment to do dissolution tests of tablets and capsules, developed exactely according to the Pharmacopeia standards. It consists of 6 or 7 round bottom reaction glass vessels with removable covers, placed in a thermostatic bath at 37ºC, with sincronized and perfectly balanced padle stirrers, to prevent any vibration. Each padle or basket, can be introduced or removed individually from the vessel for cleaning, changing and handling the samples. The whole upper part can be lifted. According to the standards used, it is possible to use padles (supplied with the apparatus), or basket stirrers (as accessories), to do the tests according to the American standards. Produced two models ITDD-06 6 vessels, ITDD-07 7vessels.
  • Technical data
    • Sturdy metallic painted housing. Overall dimensions in mm D440, H495, W610. Weight 42Kg. 230V 1200W.
    • Speed 20~200RPM. bath temperature +37ºC ±0,5ºC (regulable) with overheating safety DIN 12879.
    • Padles, heater and pump made of stainless steel.
    • Polycarbonate thermostatic bath.
    • Protection class according to DIN EN 60529 IP33.
    • Permissible ambient temperature +4 ~ +40 °C.
    • Permissible relative humidity 80%.
    • Standards: They are in full compliance to the valid USP<711/724>, EP<2.9.3/4> and many international Pharmacopoeias USB, BP, DAB.
  • Accessories
    • ITDDX-1 Stirrer with basket
    • ITDDX-2 Padle of stainless steel PTFE coated
    • DBP-08 Peristaltic pump 8 channels. Flow 0,03~6,24ml/min.


DISINTEGRATION TEST

  • Description
     Equipment to perform test the disintegration time of the tablets (coated or not), capsules and similars, developed exactely to follow the Fharmacopeia indications according to the main standards. It consists of a basket with 6 glass tubes where the tablets to be tested are placed; provided with a 30 OPM constant vertical reciprocating motion, with a stroke of 55mm, to be introduced and removed cyclically into a glass beaker, placed into a water bath at 37ºC. Exchangeable baskets for “B” Ø30mm tubes. Two models are produced: ITDI-01 1 basket, ITDI-02 2 baskets
  • Technical data

    • Metallic painted and stainless steel housing.
    • Overall dimensions in mm D500, H400, W310.
    • Weight 12Kg. 230V. 600W. Speed 30 OPM.
    • Bath temperature +37ºC ±0,1ºC.
    • Timer between 1 second to 24 hours.
    • Polycarbonate thermostatic bath with overheating safety DIN 12879.
    • Protection class according to DIN EN 60529 IP33.
    • Permissible ambient temperature +4 ~ +40°C.
    • Permissible relative humidity 80% Standards: They are in full compliance to the valid USP <701/2040> and EP <2.9.1/ Test A and B> monograph, and many international Pharmacopoeias, BP, DAB, JP.
  • Accessories
    • ITDIX-1Set of 6 ballast disk.
    • ITDIX-2Basket for “B” Ø30mm tubes for USP<2040> and EP<2.9.1.2>


FRIABILATOR

  • Theory
     The tablets must have sufficient mechanical strength to ensure that they will arrive to the end user in the same conditions as they have been produced. One of the most agressive situations is packing and transport. For this reason, it is convenient to design a test capable to simulate the expected agressions. For this purpose, two tests are developed to measure this parameters THE FRIABILITY TEST, and THE ABRASION TEST. Description
     It consists of a motor that produces a rotatory motion paralel to the working bench; at the end of the motor axle, there is a drum attached , where the samples are introduced, they are weighed before starting the test; when the test is finished, the samples are reweighted again; the weight difference is the weight loss.

    • FRIABILITY DRUM: 300 mmØ is made of acrilic plastic, and it is provided with a “Comma” shape internal device, that makes the tablets, do a continous rolling and falling constant motions, in order to simulate the friability effects, and measure them.
    • ABRASION DRUM: 200mm Ø, with 12 blades with 10º angle, make the tablets move up, slide and fall; this motion crumbles them.
  • Technical data
    • Metallic painted housing.
    • Overall dimensions in mm D320, H300, W250 Weight 18Kg. 230V 30W.
    • Speed 20~60RPM ±1RPM. Timer 1~60min.
    • Protection class according to DIN EN 60529 IP 33.
    • Permissible ambient temperature +4 ~ +40°C.
    • Permissible relative humidity 80%.
    • Supplied complete with 2 drums (Friablity + Abrasion).
    • Standards They are in full compliance to the valid USP<1216>, EP<2.9.7>, and international pharmacopoeias BP, DAB,JP.
  • Accessories
     ITDAX-1 Friability drum ITDAX-2 Abrasion drum ITDAX-3 Support to inclinate 10º the unit position for compilance standards USP/EP


POWDER FLOWABILITY TEST

  • Theory
    This analysis method is intended to determine the ability of powders, granules and similar products, to flow vertically under the action of the gravity and other forces, under defined conditions, according to the British & European Pharmacopeia and other. 
  • Description
    It consists of a dish with 20 holes of different diameters each one, as follows: 4-5-6-7-8-9-10-11-12-14-16-18-20-22-24-26-28-30-32-34mm Ø. The dish can rotate by hand, to choose the hole diameter and put it on line with the upper stainless steel (to prevent the electrostatic powder adherence) funnel and the down beaker. The sample is introduced into the funnel, it must cross the hole, and fall into the beaker, measuring the used time through a chronometer.
  • Technical data
    • The support stand and the dish are made of stainless steel AISI 316, the hole diameters are marked one by one in each hole.
    • Overall dimensions in mm D340, H350, W270.
    • Weight 8Kg.
    • Permissible ambient temperature +4 ~ +40 °C. Permissible relative humidity 80%.
  • Standards
    EP 5.0 1/2005:20917 Chapter 2.9.36 ~ASTM D 6393-08~USP Chapter 1174 and European Pharmacopoeia. Domestic detergents (ISO 4324) . Agricultural fertilizers (ISO 8398, DIN EN 12047)

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